Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors. (NCT NCT04642365)

NCT ID: NCT04642365

Last Updated: 2025-05-21

Results Overview

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 49 participants
• Primary outcome timeframe: From Day 1 up to the end of safety follow-up (up to 28.5 months)
• Results posted on: 2025-05-21

Participant Flow

A total of 49 participants took part in the study across 10 investigative sites in 6 countries. This study was planned to be conducted in 3 parts. Part 1 (Dose-escalation): ascending doses of RO7296682 + fixed dose of atezolizumab, Part 2 (Dose expansion): fixed dose of RO7296682 + atezolizumab and Part 3 (Exploratory). Part 2 was prematurely terminated and Part 3 was not opened for enrollment due to study termination.

Participants with advanced and/or metastatic non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), esophageal cancer (EsC), triple-negative breast cancer (TNBC), and ovarian cancer (OvCa) who progressed on all standard therapies, were intolerant to standard of care (SoC), and/or were non-amenable to SoC/for whom SoC did not exist were enrolled in Part 1 cohorts.

Participant milestones

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg Participants received RO7296682, 0.3 milligrams (mg) as an intravenous (IV) infusion in combination with atezolizumab, 1200 mg, as an IV infusion every 3 week (Q3W) for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Overall Study STARTED	6	6	7	7	7	6	7	3
Overall Study COMPLETED	0	0	0	0	1	0	0	0
Overall Study NOT COMPLETED	6	6	7	7	6	6	7	3

Reasons for withdrawal

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg Participants received RO7296682, 0.3 milligrams (mg) as an intravenous (IV) infusion in combination with atezolizumab, 1200 mg, as an IV infusion every 3 week (Q3W) for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Overall Study Death	3	2	4	5	5	3	2	1
Overall Study Physician Decision	1	0	0	0	0	0	0	0
Overall Study Progressive Disease	1	1	1	0	0	0	1	0
Overall Study Study Terminated By Sponsor	0	2	1	1	1	2	2	1
Overall Study Symptomatic Deterioration	1	1	0	0	0	1	0	0
Overall Study Withdrawal by Subject	0	0	1	1	0	0	2	0
Overall Study Adverse Event	0	0	0	0	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.

Baseline characteristics by cohort

Measure	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.	Total n=49 Participants Total of all reporting groups	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.
Age, Continuous	57.1 years STANDARD_DEVIATION 9.7 • n=115 Participants	55.3 years STANDARD_DEVIATION 8.6 • n=24 Participants	60.8 years STANDARD_DEVIATION 10.8 • n=42 Participants	54.5 years STANDARD_DEVIATION 12.4 • n=5 Participants	61.7 years STANDARD_DEVIATION 10.5 • n=7 Participants	62.6 years STANDARD_DEVIATION 10.1 • n=5 Participants	62.0 years STANDARD_DEVIATION 13.3 • n=4 Participants	66.4 years STANDARD_DEVIATION 9.7 • n=21 Participants	63.0 years STANDARD_DEVIATION 10.9 • n=10 Participants
Sex: Female, Male Female	5 Participants n=115 Participants	1 Participants n=24 Participants	23 Participants n=42 Participants	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=115 Participants	2 Participants n=24 Participants	26 Participants n=42 Participants	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	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=10 Participants
Race (NIH/OMB) Asian	0 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	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=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	7 Participants n=115 Participants	3 Participants n=24 Participants	46 Participants n=42 Participants	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	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=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	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=10 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	7 Participants n=115 Participants	3 Participants n=24 Participants	47 Participants n=42 Participants	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants
Race/Ethnicity, Customized Missing	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: From Day 1 up to the end of safety follow-up (up to 28.5 months)

Population: Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1: Number of Participants With Adverse Events (AEs)	6 Participants	6 Participants	7 Participants	7 Participants	7 Participants	5 Participants	7 Participants	—

PRIMARY outcome

Timeframe: From Day 1 up to the end of safety follow-up (up to 9.3 months)

Population: Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=3 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 2: Number of Participants With AEs	3 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 up Cycle 2 Day 8 (1 Cycle = 21 days)

Population: DLT evaluable population included participants who completed the DLT period with two administrations of RO7296682/atezolizumab without DLT, or participants reported with a DLT.

A DLT was defined as the occurrence of any of the following toxicities related to RO7296682 and atezolizumab that occurs during the DLT assessment window and not attributable to the underlying disease or an intercurrent illness: Any Grade ≥ 3 hematologic toxicity; Any Grade ≥ 3 non-hematologic toxicity; any other RO7296682-related toxicity considered significant enough to qualify as a DLT in the opinion of the Investigator and after discussion with the Sponsor.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)

Population: Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.

ORR was determined as the percentage of participants with an overall response (OR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=3 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 2: Objective Response Rate (ORR)	0 percentage of participants Interval 0.0 to 70.76	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 up to end of safety follow-up (up to 28.5 months)

Population: Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.

ORR was determined as the percentage of participants with an OR of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1: ORR	0 percentage of participants Interval 0.0 to 52.18	0 percentage of participants Interval 0.0 to 45.93	0 percentage of participants Interval 0.0 to 40.96	0 percentage of participants Interval 0.0 to 40.96	28.6 percentage of participants Interval 3.67 to 70.96	16.7 percentage of participants Interval 0.42 to 64.12	0 percentage of participants Interval 0.0 to 40.96	—

SECONDARY outcome

Timeframe: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)

Population: Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.

DCR was determined as the rate of participants with an OR of either CR, PR, or stable disease (SD) rate as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off to the nearest decimal point.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Disease Control Rate (DCR)	40.0 percentage of participants Interval 5.27 to 85.34	33.3 percentage of participants Interval 4.33 to 77.72	57.1 percentage of participants Interval 18.41 to 90.1	42.9 percentage of participants Interval 9.9 to 81.59	71.4 percentage of participants Interval 29.04 to 96.33	66.7 percentage of participants Interval 22.28 to 95.67	14.3 percentage of participants Interval 0.36 to 57.87	33.3 percentage of participants Interval 0.84 to 90.57

SECONDARY outcome

Timeframe: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)

Population: Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable.

DOR was calculated for participants who had a best OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD/death (within 30 days from last treatment) were censored on the last day of tumor assessment. Participants without post-baseline (PB) or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=2 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=1 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Duration of Response (DoR)	—	—	—	—	156 days Interval 105.0 to 207.0	364.00 days Interval 364.0 to 364.0	—	—

SECONDARY outcome

Timeframe: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)

Population: Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable. Overall number analyzed is the number of participants with data available for analysis.

PFS was defined as the time from study treatment initiation to the first occurrence of documented PD (per RECIST v1.1) or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD or death (within 30 days from last treatment) were censored at the last day of tumor assessment. Participants without PB or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=4 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Progression-Free Survival (PFS)	52.0 days Interval 23.0 to The upper limit of the 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.	58.0 days Interval 56.0 to 103.0	121.0 days Interval 70.0 to 148.0	59.0 days Interval 31.0 to 225.0	135.0 days Interval 53.0 to 182.0	111.0 days Interval 105.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	51.5 days Interval 46.0 to 57.0	69.0 days Interval 57.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Part 1: From Day 1 up to end of survival follow-up (36 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)

Population: Efficacy population included all participants who received at least one dose of RO7296682 in combination with atezolizumab, and who had at least one baseline and one on-study tumor assessment and discontinued the study because of progression before the first on-study tumor assessment were considered response evaluable. Overall number analyzed is the number of participants with data available for analysis.

OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up).

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=4 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=4 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=3 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=3 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=2 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Overall Survival (OS)	181.0 days Interval 36.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	295.0 days Interval 84.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	352.0 days Interval 263.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	237.0 days Interval 213.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	353.0 days Interval 129.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	230.0 days Interval 111.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	304.0 days Interval 137.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	73.0 days Interval 69.0 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Area Under the Curve From Time of Dosing to the Last Timepoint at the End of the Dosing Period (AUClast) of RO7296682 Cycle 1	14.3 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 89.3	83.7 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 50.2	507 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 43.9	1050 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 26.9	2100 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 50.8	3860 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 22.3	9890 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 23.8	NA hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Part 1 and 2: Area Under the Curve From Time of Dosing to the Last Timepoint at the End of the Dosing Period (AUClast) of RO7296682 Cycle 4	19.4 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 79.8	109 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 34.9	599 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 45.3	1130 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 146	2780 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 82.5	5460 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 8.20	16700 hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation 0.708	NA hours*micrograms/milliliters (h*μg/mL) Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Maximum Concentration (Cmax) of RO7296682 Cycle 1	0.0921 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 54.1	0.555 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 22.2	3.18 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 19.3	8.23 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 32.8	12.7 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 40.9	27.3 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 34.5	61.7 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 17.5	NA micrograms/milliliters (μg/mL) Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Part 1 and 2: Maximum Concentration (Cmax) of RO7296682 Cycle 4	0.119 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 66.3	0.544 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 28.8	3.27 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 21.0	7.82 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 40.4	15.3 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 43.9	34.2 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 27.8	85.2 micrograms/milliliters (μg/mL) Geometric Coefficient of Variation 4.32	NA micrograms/milliliters (μg/mL) Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Time of Maximum Concentration (Tmax) of RO7296682 Cycle 1	5.53 hours Interval 4.12 to 6.75	4.15 hours Interval 4.0 to 7.28	4.17 hours Interval 3.92 to 19.9	4.92 hours Interval 4.0 to 6.67	4.07 hours Interval 4.0 to 7.0	4.07 hours Interval 4.0 to 26.0	4.13 hours Interval 4.0 to 5.67	NA hours Samples were below the limit of quantification, hence median and full range were unevaluable.
Part 1 and 2: Time of Maximum Concentration (Tmax) of RO7296682 Cycle 4	1.41 hours Interval 1.0 to 4.0	1.17 hours Interval 1.0 to 4.08	1.15 hours Interval 1.05 to 2.93	NA hours Interval 1.05 to 23.0 Median values cannot be derived for two participants.	1.17 hours Interval 1.0 to 3.75	NA hours Interval 1.22 to 3.5 Median values cannot be derived for two participants.	NA hours Interval 1.08 to 1.27 Median values cannot be derived for two participants.	NA hours Samples were below the limit of quantification, hence median and full range were unevaluable.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Volume of Distribution at Steady State Conditions (Vss) of RO7296682 Cycle 4	5.75 Litre (L) Geometric Coefficient of Variation 142	6.12 Litre (L) Geometric Coefficient of Variation 19.4	5.59 Litre (L) Geometric Coefficient of Variation 41.3	6.50 Litre (L) Geometric Coefficient of Variation 10.5	5.59 Litre (L) Geometric Coefficient of Variation 44.8	3.96 Litre (L) Geometric Coefficient of Variation 24.2	5.22 Litre (L) Geometric Coefficient of Variation 5.82	NA Litre (L) Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Part 1 and 2: Volume of Distribution at Steady State Conditions (Vss) of RO7296682 Cycle 1	6.91 Litre (L) Geometric Coefficient of Variation 49.8	5.41 Litre (L) Geometric Coefficient of Variation 16.9	5.31 Litre (L) Geometric Coefficient of Variation 33.6	5.94 Litre (L) Geometric Coefficient of Variation 12.8	7.29 Litre (L) Geometric Coefficient of Variation 45.3	6.14 Litre (L) Geometric Coefficient of Variation 50.7	5.84 Litre (L) Geometric Coefficient of Variation 42.1	NA Litre (L) Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.

SECONDARY outcome

Timeframe: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Half-life (t~1/2) of RO7296682 Cycle 1	10.1 days Geometric Coefficient of Variation 40.2	8.89 days Geometric Coefficient of Variation 32.8	8.91 days Geometric Coefficient of Variation 29.7	9.43 days Geometric Coefficient of Variation 31.1	10.8 days Geometric Coefficient of Variation 21.6	9.15 days Geometric Coefficient of Variation 42.4	11.2 days Geometric Coefficient of Variation 49.7	NA days Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.
Part 1 and 2: Half-life (t~1/2) of RO7296682 Cycle 4	10.3 days Geometric Coefficient of Variation 25.3	13.2 days Geometric Coefficient of Variation 53.0	10.8 days Geometric Coefficient of Variation 51.2	12.1 days Geometric Coefficient of Variation 109	9.65 days Geometric Coefficient of Variation 32.1	7.92 days Geometric Coefficient of Variation 3.64	15.3 days Geometric Coefficient of Variation 4.28	NA days Geometric Coefficient of Variation NA Samples were below the limit of quantification, hence geometric mean and geometric coefficient of variation were unevaluable.

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1 to 9, 12, 14, and 17; End of infusion (EOI) on Day 1 of Cycles 1 and 4; end of study/early discontinuation (up to 28.5 months)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

1 Cycle = 21 days.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=5 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=2 Participants Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1: Serum Concentration of Atezolizumab Cycle 8 Day 1 Predose	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	209 μg/mL Geometric Coefficient of Variation 36.0	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—	238 μg/mL Geometric Coefficient of Variation 39.0	—	—	—
Part 1: Serum Concentration of Atezolizumab Cycle 17 Day 1 Predose	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—	—	—	—	—	—	—
Part 1: Serum Concentration of Atezolizumab End of Study	135 μg/mL Geometric Coefficient of Variation 37.9	105 μg/mL Geometric Coefficient of Variation 37.4	141 μg/mL Geometric Coefficient of Variation 34.0	74.1 μg/mL Geometric Coefficient of Variation 21.1	112 μg/mL Geometric Coefficient of Variation 16.4	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	61.3 μg/mL Geometric Coefficient of Variation 13.0	—
Part 1: Serum Concentration of Atezolizumab Cycle 1 Day 1 - EOI	432 μg/mL Geometric Coefficient of Variation 25.9	387 μg/mL Geometric Coefficient of Variation 17.7	427 μg/mL Geometric Coefficient of Variation 32.4	374 μg/mL Geometric Coefficient of Variation 19.5	363 μg/mL Geometric Coefficient of Variation 29.5	379 μg/mL Geometric Coefficient of Variation 23.3	492 μg/mL Geometric Coefficient of Variation 13.1	410 μg/mL Geometric Coefficient of Variation 25.8
Part 1: Serum Concentration of Atezolizumab Cycle 2 Day 1 - Predose	65.7 μg/mL Geometric Coefficient of Variation 91.5	74.6 μg/mL Geometric Coefficient of Variation 44.6	98.2 μg/mL Geometric Coefficient of Variation 39.4	65.8 μg/mL Geometric Coefficient of Variation 21.6	58.0 μg/mL Geometric Coefficient of Variation 72.2	67.4 μg/mL Geometric Coefficient of Variation 50.0	87.9 μg/mL Geometric Coefficient of Variation 46.3	—
Part 1: Serum Concentration of Atezolizumab Cycle 4 Day 1 Predose	180 μg/mL Geometric Coefficient of Variation 29.2	131 μg/mL Geometric Coefficient of Variation 29.1	130 μg/mL Geometric Coefficient of Variation 41.7	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, Geometric mean (GM) and Geometric Coefficient of Variation could not be estimated.	159 μg/mL Geometric Coefficient of Variation 42.5	115 μg/mL Geometric Coefficient of Variation 56.4	260 μg/mL Geometric Coefficient of Variation 16.9	—
Part 1: Serum Concentration of Atezolizumab Cycle 1 Day 1 Predose	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were below limit of quantification (BLQ).	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.	NA μg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation was not estimable as samples were BLQ.
Part 1: Serum Concentration of Atezolizumab Cycle 3 Day 1 Predose	153 μg/mL Geometric Coefficient of Variation 32.4	177 μg/mL Geometric Coefficient of Variation 75.2	89.9 μg/mL Geometric Coefficient of Variation 98.8	84.0 μg/mL Geometric Coefficient of Variation 49.1	121 μg/mL Geometric Coefficient of Variation 35.5	82.4 μg/mL Geometric Coefficient of Variation 39.8	181 μg/mL Geometric Coefficient of Variation 35.1	—
Part 1: Serum Concentration of Atezolizumab Cycle 4 Day 1 - EOI Atezo	566 μg/mL Geometric Coefficient of Variation 15.7	527 μg/mL Geometric Coefficient of Variation 8.40	450 μg/mL Geometric Coefficient of Variation 28.0	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	512 μg/mL Geometric Coefficient of Variation 35.9	510 μg/mL Geometric Coefficient of Variation 14.8	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—
Part 1: Serum Concentration of Atezolizumab Cycle 5 Day 1 Predose	194 μg/mL Geometric Coefficient of Variation 40.9	153 μg/mL Geometric Coefficient of Variation 33.0	151 μg/mL Geometric Coefficient of Variation 60.0	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	190 μg/mL Geometric Coefficient of Variation 31.6	162 μg/mL Geometric Coefficient of Variation 26.4	—	—
Part 1: Serum Concentration of Atezolizumab Cycle 6 Day 1 Predose	194 μg/mL Geometric Coefficient of Variation 11.7	139 μg/mL Geometric Coefficient of Variation 112	160 μg/mL Geometric Coefficient of Variation 51.1	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	237 μg/mL Geometric Coefficient of Variation 23.4	169 μg/mL Geometric Coefficient of Variation 44.8	—	—
Part 1: Serum Concentration of Atezolizumab Cycle 7 Day 1 Predose	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	201 μg/mL Geometric Coefficient of Variation 52.4	154 μg/mL Geometric Coefficient of Variation 64.5	—	265 μg/mL Geometric Coefficient of Variation 9.61	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—	—
Part 1: Serum Concentration of Atezolizumab Cycle 9 Day 1 Predose	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—	—	—
Part 1: Serum Concentration of Atezolizumab Cycle 12 Day 1 Predose	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—	—	—	—	—	—	—
Part 1: Serum Concentration of Atezolizumab Cycle 14 Day 1 Predose	NA μg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, GM and Geometric Coefficient of Variation could not be estimated.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 28 days post last dose (up to 24.9 months)

Population: Pharmacodynamic (PD) evaluable population included all participants who had at least one pre-dose and one post-dose PD assessment were included and analyzed according to the treatment they actually received.

Treg depletion was defined as a reduction to 25% of baseline. As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Number of Participants With Treatment-induced Changes in T Regulatory C Ells (Treg) Levels in Blood and/or Tumor as Compared to Baseline	1 Participants	1 Participants	5 Participants	5 Participants	7 Participants	5 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (end of infusion [EOI]); Cycle 1 Day 4 (72 hours post dose); Cycle 1 Day 8 (168 hours post dose); Cycle 1 Day 15 (336 hours post dose)

Population: Pharmacodynamic (PD) evaluable population included all participants who had at least one pre-dose and one post-dose PD assessment were included and analyzed according to the treatment they actually received. Number analyzed per timepoint are unique number of participants out all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.

As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.

Outcome measures

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 Participants Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 Participants Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline Cycle 1 Day 4 (72 hours Post-dose)	0.69 ratio Standard Deviation 0.78	0.17 ratio Standard Deviation NA Since only 1 participant was evaluated, standard deviation could not be calculated.	0.30 ratio Standard Deviation 0.12	0.60 ratio Standard Deviation 1.06	0.19 ratio Standard Deviation 0.22	0.29 ratio Standard Deviation 0.31	0.52 ratio Standard Deviation 0.47	—
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline Cycle 1 Day 8 (168 hours Post-dose)	1.55 ratio Standard Deviation 1.37	0.26 ratio Standard Deviation 0.29	0.29 ratio Standard Deviation 0.22	0.48 ratio Standard Deviation 0.58	0.36 ratio Standard Deviation 0.30	0.16 ratio Standard Deviation 0.11	0.19 ratio Standard Deviation 0.10	—
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline Cycle 1 Day 15 (336 hours Post-dose)	1.20 ratio Standard Deviation 0.92	0.97 ratio Standard Deviation 0.16	0.42 ratio Standard Deviation 0.38	4.24 ratio Standard Deviation 7.89	0.39 ratio Standard Deviation 0.29	0.33 ratio Standard Deviation 0.29	0.27 ratio Standard Deviation 0.19	—
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline Cycle 1 Day 1 (EOI)	1.59 ratio Standard Deviation 1.43	0.83 ratio Standard Deviation 0.67	0.41 ratio Standard Deviation 0.15	0.27 ratio Standard Deviation 0.20	0.37 ratio Standard Deviation 0.60	0.68 ratio Standard Deviation 0.92	0.32 ratio Standard Deviation 0.12	—

Adverse Events

Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 4 deaths

Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 4 deaths

Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 5 deaths

Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg

Serious events: 4 serious events

Other events: 7 other events

Deaths: 5 deaths

Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 3 deaths

Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg

Serious events: 4 serious events

Other events: 7 other events

Deaths: 3 deaths

Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 participants at risk Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 participants at risk Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 participants at risk Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 participants at risk Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Colitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Pancreatitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Pyrexia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Hepatobiliary disorders Hepatitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Immune system disorders Immune system disorder	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations COVID-19 pneumonia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Enterocolitis bacterial	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Respiratory tract infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood creatinine increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Carotid sinus syndrome	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Confusional state	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.

Other adverse events

Measure	Part 1: Cohort 1 - RO7296682 0.3 mg + Atezolizumab 1200 mg n=6 participants at risk Participants received RO7296682, 0.3 mg as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 13.2 months.	Part 1: Cohort 2 - RO7296682 1.5 mg + Atezolizumab 1200 mg n=6 participants at risk Participants received RO7296682, 1.5 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 23.7 months.	Part 1: Cohort 3 - RO7296682 9 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 9 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 12 months.	Part 1: Cohort 4 - RO7296682 20 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 20 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 16.6 months.	Part 1: Cohort 5 - RO7296682 40 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 40 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 8.6 months.	Part 1: Cohort 6 - RO7296682 80 mg + Atezolizumab 1200 mg n=6 participants at risk Participants received RO7296682, 80 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 24 months.	Part 1: Cohort 7 - RO7296682 160 mg + Atezolizumab 1200 mg n=7 participants at risk Participants received RO7296682, 160 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 2.8 months.	Part 2: Cohort 1 - RO7296682 70 mg + Atezolizumab 1200 mg n=3 participants at risk Participants with advanced and/or metastatic NSCLC, MEL, HNSCC with inflamed tumor phenotype and acquired resistance to most recent programmed death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) treatment received RO7296682, 70 mg, as an IV infusion in combination with atezolizumab, 1200 mg, as an IV infusion Q3W for a maximum of 5.5 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Palpitations	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Tachycardia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Adrenal insufficiency	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Hyperthyroidism	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Hypothyroidism	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Cataract	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Lacrimation increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Scleral haemorrhage	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Visual impairment	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Ascites	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Breath odour	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 5 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Glossodynia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Oral pruritus	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Tongue ulceration	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Umbilical hernia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Vomiting	50.0% 3/6 • Number of events 7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Asthenia	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Chest pain	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Chills	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Face oedema	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Fatigue	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	71.4% 5/7 • Number of events 5 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	66.7% 4/6 • Number of events 6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Mucosal dryness	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Necrosis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Oedema peripheral	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Pain	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Peripheral swelling	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
General disorders Pyrexia	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Immune system disorders Seasonal allergy	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Body tinea	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations COVID-19	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Campylobacter infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Candida infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Fungal infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Fungal skin infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Gastroenteritis	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Groin infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Herpes zoster	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Labyrinthitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Oral candidiasis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Oral herpes	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Pneumonia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Respiratory tract infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Urinary tract infection	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Limb injury	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Vascular access site erythema	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood creatinine increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Electrocardiogram QT prolonged	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Eosinophil count increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Gamma-glutamyltransferase increased	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Lymphocyte count decreased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Neutrophil count decreased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Neutrophil count increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Platelet count decreased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations Weight decreased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Investigations White blood cell count increased	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypokalaemia	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dysgeusia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Secondary cerebellar degeneration	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Transient ischaemic attack	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Anxiety	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Restlessness	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Dysuria	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 5 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Tonsillar ulcer	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Pruritus	33.3% 2/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 5 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	71.4% 5/7 • Number of events 7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	57.1% 4/7 • Number of events 5 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	57.1% 4/7 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 1/3 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	85.7% 6/7 • Number of events 8 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	66.7% 2/3 • Number of events 3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	42.9% 3/7 • Number of events 5 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	28.6% 2/7 • Number of events 2 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 4 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin hypertrophy	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin plaque	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Flushing	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hot flush	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hypotension	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/7 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	14.3% 1/7 • Number of events 1 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/3 • Part 1: AEs: From Day 1 up to the end of safety follow-up (up to 28.5 months) All-cause Mortality: Part 1: From Day 1 up to end of survival follow-up (36 months) Part 2: AEs and All-cause Mortality: From Day 1 up to the end of safety follow-up (up to 9.3 months) Safety population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER