Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors (NCT NCT05407675)

Last Updated: 2025-10-03

Results Overview

A Dose-Limiting Toxicity (DLT) is defined as a treatment-related adverse event that meets specific severity criteria, excluding those clearly due to disease progression or unrelated causes. DLTs include: any Grade ≥3 non-hematologic toxicity (with exceptions like transient nausea, fatigue, rash, or electrolyte imbalances), significant liver enzyme elevations, Grade 4 neutropenia \>7 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, febrile neutropenia, and any Grade ≥3 immune-mediated toxicity including myocarditis, myelitis, or severe skin reactions. Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

68 participants

Primary outcome timeframe

From first dose (Day 1) till 28 days

Results posted on

2025-10-03

Participant Flow

Participants were not enrolled in Part 3.

Participant milestones

Participant milestones
Measure	Part 1 (Group A) BMS-986408 0.75 mg QD Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 Group C BMS-986408 5 mg QD Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Overall Study STARTED	3	6	7	11	3	4	5	2	6	7	8	5	1
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	6	7	11	3	4	5	2	6	7	8	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 (Group A) BMS-986408 0.75 mg QD Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 Group C BMS-986408 5 mg QD Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Overall Study Withdrawal by Subject	0	2	3	5	0	2	0	0	2	0	1	0	0
Overall Study Site terminated by sponsor	0	0	1	0	2	0	1	0	0	2	2	2	1
Overall Study Disease Progression	0	0	0	0	0	0	0	0	0	0	1	0	0
Overall Study Physician Decision	0	0	0	0	0	0	0	0	0	0	1	0	0
Overall Study Other reasons	0	0	0	0	0	0	0	0	1	1	1	1	0
Overall Study Death	3	4	3	6	0	2	4	2	2	4	2	1	0
Overall Study Adverse Event	0	0	0	0	1	0	0	0	0	0	0	1	0
Overall Study Ongoing Treatment	0	0	0	0	0	0	0	0	1	0	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=6 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=4 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=2 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 Group C BMS-986408 5 mg QD n=7 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Total n=68 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 10.02 • n=5 Participants	57.8 years STANDARD_DEVIATION 15.41 • n=7 Participants	62.3 years STANDARD_DEVIATION 13.15 • n=5 Participants	57.4 years STANDARD_DEVIATION 12.57 • n=4 Participants	67.0 years STANDARD_DEVIATION 13.08 • n=21 Participants	52.5 years STANDARD_DEVIATION 10.08 • n=8 Participants	67.0 years STANDARD_DEVIATION 6.44 • n=8 Participants	70.5 years STANDARD_DEVIATION 12.02 • n=24 Participants	68.0 years STANDARD_DEVIATION 6.63 • n=42 Participants	55.9 years STANDARD_DEVIATION 10.61 • n=42 Participants	62.9 years STANDARD_DEVIATION 9.11 • n=42 Participants	57.2 years STANDARD_DEVIATION 13.86 • n=42 Participants	70.0 years STANDARD_DEVIATION NA • n=36 Participants	60.8 years STANDARD_DEVIATION 11.50 • n=36 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	33 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=36 Participants	35 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	7 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	7 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=36 Participants	55 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	6 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	5 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	5 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=36 Participants	48 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	10 Participants n=36 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) till 28 days

Population: Participants were DLT evaluable if they received ≥75% of planned BMS-986408 doses without a DLT or had a DLT after at least one dose. In Part 2, they must also have received one nivolumab dose.

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD n=3 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=2 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=4 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=6 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=9 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=3 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=4 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=2 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=2 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Number of Participants With Dose Limiting Toxicities (DLTs)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 untill 100 days after last dose (up to approximately 15 months) for group D

Population: Safety population included all participants who received at least 1 dose of study intervention

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD n=7 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=6 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=4 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=2 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Number of Participants With Adverse Events Any Adverse Events	7 Participants	8 Participants	5 Participants	3 Participants	6 Participants	6 Participants	11 Participants	3 Participants	4 Participants	5 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Adverse Events Any Drug-related AEs	6 Participants	6 Participants	5 Participants	2 Participants	4 Participants	3 Participants	11 Participants	3 Participants	4 Participants	4 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Adverse Events Serious Adverse Events	3 Participants	3 Participants	3 Participants	2 Participants	1 Participants	2 Participants	7 Participants	2 Participants	3 Participants	4 Participants	2 Participants	4 Participants	1 Participants
Number of Participants With Adverse Events AEs leading to Discontinuation	3 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months)

Population: Safety population included all participants who received at least 1 dose of study intervention

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD n=7 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=6 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=4 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=2 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Number of Participants Who Died	3 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	4 Participants	0 Participants	3 Participants	2 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)

Population: PK evaluable population included all treated participants who have any available concentration-time data. Only participants with available concentration-time data at particular timepoint were included in the analysis.

Blood samples were collected to assess pharmacokinetic parameters

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD n=7 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=5 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=3 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=1 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Maximum Observed Plasma Concentration (Cmax) of BMS-986408 Cycle 1 Day 1	19.43 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 41.43	5.07 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 36.26	10.71 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 46.81	2.49 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 61.05	4.86 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 37.36	8.56 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 35.16	15.00 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 45.02	15.99 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 64.67	5.57 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 34.38	9.98 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 21.58	11.20 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed	12.62 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 37.65	15.50 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed
Maximum Observed Plasma Concentration (Cmax) of BMS-986408 Cycle 1 Day 15	61.55 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 32.92	—	—	9.32 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 63.71	17.66 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 36.70	22.19 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 51.79	62.97 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 80.05	41.27 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 26.51	33.14 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 61.85	67.55 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 40.90	30.10 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed	28.43 nanogram per mililitre (ng/mL) Geometric Coefficient of Variation 39.76	—

SECONDARY outcome

Timeframe: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)

Blood samples were collected to assess pharmacokinetic parameters

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD n=7 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=5 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=3 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=1 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986408 Cycle 1 Day 15	4.14 hours Geometric Coefficient of Variation 2.57	—	—	2.56 hours Geometric Coefficient of Variation 90.49	4.02 hours Geometric Coefficient of Variation 62.27	4.72 hours Geometric Coefficient of Variation 89.13	3.12 hours Geometric Coefficient of Variation 62.02	2.96 hours Geometric Coefficient of Variation 115.92	3.71 hours Geometric Coefficient of Variation 59.62	2.45 hours Geometric Coefficient of Variation 28.62	2.10 hours Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed	2.83 hours Geometric Coefficient of Variation 41.44	—
Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986408 Cycle 1 Day 1	4.84 hours Geometric Coefficient of Variation 21.23	3.90 hours Geometric Coefficient of Variation 48.23	4.75 hours Geometric Coefficient of Variation 22.10	2.52 hours Geometric Coefficient of Variation 42.77	4.62 hours Geometric Coefficient of Variation 23.00	4.22 hours Geometric Coefficient of Variation 39.23	4.28 hours Geometric Coefficient of Variation 43.77	5.38 hours Geometric Coefficient of Variation 20.62	4.11 hours Geometric Coefficient of Variation 3.08	3.57 hours Geometric Coefficient of Variation 27.06	4.17 hours Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed	3.19 hours Geometric Coefficient of Variation 37.90	5.97 hours Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed

SECONDARY outcome

Timeframe: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)

Population: PK evaluable population included all treated participants who have any available concentration-time data. Only participants with with available concentration-time data at particular timepoint were included in the analysis.

Blood samples were collected to assess pharmacokinetic parameters.

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD n=7 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=5 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=3 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=1 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)] Cycle 1 Day 1	275.58 ng*h/mL Geometric Coefficient of Variation 34.92	72.34 ng*h/mL Geometric Coefficient of Variation 26.97	132.88 ng*h/mL Geometric Coefficient of Variation 64.47	28.20 ng*h/mL Geometric Coefficient of Variation 195.49	78.06 ng*h/mL Geometric Coefficient of Variation 26.21	127.52 ng*h/mL Geometric Coefficient of Variation 37.45	190.26 ng*h/mL Geometric Coefficient of Variation 65.52	263.11 ng*h/mL Geometric Coefficient of Variation 46.78	21.59 ng*h/mL Geometric Coefficient of Variation 39.75	47.81 ng*h/mL Geometric Coefficient of Variation 25.65	45.09 ng*h/mL Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed	177.07 ng*h/mL Geometric Coefficient of Variation 37.21	255.90 ng*h/mL Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)] Cycle 1 Day 15	736.15 ng*h/mL Geometric Coefficient of Variation 131.38	—	—	188.79 ng*h/mL Geometric Coefficient of Variation 74.03	251.19 ng*h/mL Geometric Coefficient of Variation 83.24	435.29 ng*h/mL Geometric Coefficient of Variation 48.55	1252.68 ng*h/mL Geometric Coefficient of Variation 74.84	492.07 ng*h/mL Geometric Coefficient of Variation 124.61	178.12 ng*h/mL Geometric Coefficient of Variation 67.11	377.22 ng*h/mL Geometric Coefficient of Variation 38.40	170.18 ng*h/mL Geometric Coefficient of Variation NA Not applicable as only 1 participant analyzed	360.41 ng*h/mL Geometric Coefficient of Variation 132.44	—

SECONDARY outcome

Timeframe: From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months)

Population: Safety population included all participants who received at least 1 dose of study intervention.

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD n=7 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 Participants Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=6 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 Participants Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 Participants Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 Participants Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=4 Participants Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 Participants Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=2 Participants Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Objective Response Rate (ORR) Per RECIST v1.1	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 52.2	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 45.9	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 60.2	0.0 percentage of participants Interval 0.0 to 52.2	0.0 percentage of participants Interval 0.0 to 84.2	16.7 percentage of participants Interval 0.4 to 64.1	0.0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Population: Safety population included all participants who received at least 1 dose of study intervention. Only confirmed responders were included in the analysis.

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Part 1 Group C BMS-986408 5 mg QD Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 1 (Group A) BMS-986408 0.75 mg QD Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=1 Participants Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Duration of Response Per RECIST v1.1	—	—	—	—	—	—	—	—	—	—	—	NA months Not estimable due to insufficient number of events.	—

Adverse Events

Part 1 (Group A) BMS-986408 0.75 mg QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 1 (Group A) BMS-986408 1.5 mg QD

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Part 1 (Group A) BMS-986408 3 mg QD

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Part 1 (Group A) BMS-986408 5 mg QD

Serious events: 7 serious events

Other events: 11 other events

Deaths: 6 deaths

Part 1 (Group A) BMS-986408 7.25 mg QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1 (Group B) BMS-986408 1.5 mg BID

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Part 1 (Group B) BMS-986408 2.25 mg BID

Serious events: 4 serious events

Other events: 5 other events

Deaths: 4 deaths

Part 1 (Group B) BMS-986408 3.75 mg BID

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 1 Group C BMS-986408 3 mg QD

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

Part 1 Group C BMS-986408 5 mg QD

Serious events: 3 serious events

Other events: 7 other events

Deaths: 4 deaths

Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W

Serious events: 3 serious events

Other events: 8 other events

Deaths: 3 deaths

Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 participants at risk Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=6 participants at risk Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 participants at risk Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 participants at risk Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 participants at risk Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=4 participants at risk Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 participants at risk Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=2 participants at risk Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 Group C BMS-986408 5 mg QD n=7 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Immune-mediated pancytopenia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Eye disorders Vision blurred	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Large intestine perforation	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Asthenia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Chest pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Fatigue	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Pyrexia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Infection	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Osteomyelitis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Pneumonia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Sepsis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Wound infection	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Blood bilirubin increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations General physical condition abnormal	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Brain oedema	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Ureteric rupture	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Urinary retention	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Urinary tract obstruction	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Surgical and medical procedures Assisted suicide	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Vascular disorders Embolism arterial	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	Part 1 (Group A) BMS-986408 0.75 mg QD n=3 participants at risk Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 1.5 mg QD n=6 participants at risk Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 3 mg QD n=7 participants at risk Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 5 mg QD n=11 participants at risk Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group A) BMS-986408 7.25 mg QD n=3 participants at risk Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD).	Part 1 (Group B) BMS-986408 1.5 mg BID n=4 participants at risk Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 2.25 mg BID n=5 participants at risk Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID).	Part 1 (Group B) BMS-986408 3.75 mg BID n=2 participants at risk Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID).	Part 1 Group C BMS-986408 3 mg QD n=6 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD).	Part 1 Group C BMS-986408 5 mg QD n=7 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD).	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n=8 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n=5 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n=1 participants at risk Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W).
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 3/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	27.3% 3/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	57.1% 4/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	60.0% 3/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Cardiac disorders Palpitations	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Ear and labyrinth disorders Ear discomfort	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Endocrine disorders Adrenal insufficiency	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Endocrine disorders Hypothyroidism	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Eye disorders Diplopia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Eye disorders Dry eye	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Eye disorders Photophobia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Eye disorders Vision blurred	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Eye disorders Visual impairment	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 2/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Ascites	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Colitis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	42.9% 3/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	72.7% 8/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 3/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 2/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	80.0% 4/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 2/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	83.3% 5/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	42.9% 3/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	37.5% 3/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Flatulence	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gingival swelling	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Melaena	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	42.9% 3/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	72.7% 8/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 3/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 2/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	60.0% 3/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	42.9% 3/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 4/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Regurgitation	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	36.4% 4/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 3/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 2/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	60.0% 3/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Asthenia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Chest pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Chills	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Facial pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Fatigue	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	45.5% 5/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	75.0% 3/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	60.0% 3/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	42.9% 3/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	37.5% 3/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Gait disturbance	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Malaise	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Non-cardiac chest pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Oedema peripheral	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Peripheral swelling	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Pyrexia	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	45.5% 5/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
General disorders Xerosis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Abdominal infection	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Bronchitis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations COVID-19	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Candida infection	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Ear infection	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Fungal oesophagitis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Hordeolum	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Oral candidiasis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Osteomyelitis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Pneumonia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Purulent discharge	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Rash pustular	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Rhinolaryngitis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Sinusitis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Infections and infestations Wound infection	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Amylase increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 2/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	27.3% 3/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Blood albumin decreased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Blood bilirubin increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Blood creatinine increased	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Blood fibrinogen decreased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations C-reactive protein increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations General physical condition abnormal	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Heart rate increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Lipase increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 2/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Lymphocyte count decreased	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 3/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Neutrophil count decreased	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Platelet count decreased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Troponin I increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Troponin T increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Troponin increased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Urine analysis abnormal	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations Weight decreased	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	36.4% 4/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Investigations White blood cell count decreased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Appetite disorder	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	36.4% 4/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	60.0% 3/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 2/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	57.1% 4/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 4/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	60.0% 3/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperferritinaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 2/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 2/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 2/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 2/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Dizziness	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Dysarthria	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Dysgeusia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Hemiparesis	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Neuralgia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Paraesthesia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Seizure	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Somnolence	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Nervous system disorders Tremor	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Anxiety	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Confusional state	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Depression	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Insomnia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Mental disorder	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Nervousness	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Dysuria	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Haematuria	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Proteinuria	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	42.9% 3/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	37.5% 3/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	18.2% 2/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 1/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	42.9% 3/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 1/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	9.1% 1/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	50.0% 1/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	33.3% 2/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	36.4% 4/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	25.0% 2/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	40.0% 2/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 2/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	14.3% 1/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	12.5% 1/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	20.0% 1/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	100.0% 1/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Vascular disorders Hypertension	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	28.6% 2/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.
Vascular disorders Hypotension	0.00% 0/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/11 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	66.7% 2/3 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/4 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/2 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	16.7% 1/6 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/7 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/8 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/5 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.	0.00% 0/1 • All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D. Safety population included all participants who received at least 1 dose of study intervention.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER