Trial Outcomes & Findings for A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors (NCT NCT01714739)

Last Updated: 2023-02-02

Results Overview

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

337 participants

Primary outcome timeframe

From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Results posted on

2023-02-02

Participant Flow

Part 4 and Part 6 of the study were removed from the protocol study design prior to enrolling any subjects.

Participant milestones

Participant milestones
Measure	Part 1/2 Liri 0.1 + Nivo 3 Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 3: PBO + Nivo 240 Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Overall Study STARTED	4	16	15	287	2	3	10
Overall Study COMPLETED	0	6	5	23	0	0	0
Overall Study NOT COMPLETED	4	10	10	264	2	3	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1/2 Liri 0.1 + Nivo 3 Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 3: PBO + Nivo 240 Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Overall Study Disease progression	3	5	5	204	1	3	5
Overall Study Study drug toxicity	1	1	1	15	0	0	5
Overall Study Death	0	0	0	1	0	0	0
Overall Study Adverse Event unrelated to drug	0	0	3	21	0	0	0
Overall Study Participant request to stop therapy	0	1	0	6	0	0	0
Overall Study Participant withdrew consent	0	1	0	8	0	0	0
Overall Study Lost to Follow-up	0	0	0	1	0	0	0
Overall Study Maximum clinical benefit	0	1	1	3	0	0	0
Overall Study Poor/non-comliance	0	1	0	1	0	0	0
Overall Study No longer meets study criteria	0	0	0	1	0	0	0
Overall Study Other reason	0	0	0	3	1	0	0

Baseline Characteristics

A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 3: PBO + Nivo 240 n=2 Participants Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 3: Liri 240 + Nivo 240 n=3 Participants Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Total n=337 Participants Total of all reporting groups
Age, Continuous	53.3 Years STANDARD_DEVIATION 12.09 • n=5 Participants	58.1 Years STANDARD_DEVIATION 13.11 • n=7 Participants	58.7 Years STANDARD_DEVIATION 16.85 • n=5 Participants	59.7 Years STANDARD_DEVIATION 11.37 • n=4 Participants	65.5 Years STANDARD_DEVIATION 10.61 • n=21 Participants	55.3 Years STANDARD_DEVIATION 21.08 • n=10 Participants	67.1 Years STANDARD_DEVIATION 10.40 • n=115 Participants	59.7 Years STANDARD_DEVIATION 11.81 • n=6 Participants
Age, Customized < 65 years old	4 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	184 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	5 Participants n=115 Participants	215 Participants n=6 Participants
Age, Customized >= 65 years old	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	103 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	122 Participants n=6 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	80 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	97 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	207 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants	240 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	6 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	175 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	8 Participants n=115 Participants	219 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	106 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	112 Participants n=6 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	237 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	10 Participants n=115 Participants	287 Participants n=6 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	10 Participants n=6 Participants
Race/Ethnicity, Customized American Indian / Alaska Native	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	0 Participants n=115 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	10 Participants n=6 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	29 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	29 Participants n=6 Participants

PRIMARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5	4 Participants	16 Participants	15 Participants	284 Participants	10 Participants	—	—

PRIMARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5	1 Participants	8 Participants	9 Participants	205 Participants	7 Participants	—	—

PRIMARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.

Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5	1 Participants	1 Participants	4 Participants	49 Participants	5 Participants	—	—

PRIMARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.

The number of participants who died.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
The Number of Participant Deaths in the Study - Parts 1, 2 and 5	2 Participants	7 Participants	5 Participants	219 Participants	5 Participants	—	—

PRIMARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Parts 1, 2 and 5.

Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Absolute Neutrophil Count - Grade 4	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Alanine Amino Transferase (ALT) - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Albumin - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Leukocytes - Grade 4	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Absolute Neutrophil Count - Grade 3	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Alanine Amino Transferase (ALT) - Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Albumin - Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Alkaline Phosphatase (ALP) - Grade 3	0 Participants	1 Participants	0 Participants	6 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Alkaline Phosphatase (ALP) - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Amylase, Total - Grade 3	0 Participants	0 Participants	0 Participants	8 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Amylase, Total - Grade 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 APTT - Grade 3	—	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 APTT - Grade 4	—	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Aspartate Aminotransferase (AST) - Grade 3	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Aspartate Aminotransferase (AST) - Grade 4	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Bilirubin, Total - Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Bilirubin, Total - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Calcium, Corrected - Grade 3	—	—	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Calcium, Corrected - Grade 4	—	—	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Calcium, Ionized - Grade 3	—	0 Participants	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Calcium, Ionized - Grade 4	—	0 Participants	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Calcium, Total - Grade 3	0 Participants	0 Participants	0 Participants	6 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Calcium, Total - Grade 4	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Creatine Kinase (CK) - Grade 3	—	—	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Creatine Kinase (CK) - Grade 4	—	—	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Creatinine - Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Creatinine - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Fibrinogen - Grade 3	—	—	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Fibrinogen - Grade 4	—	—	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 G-Glutamyl Transferase (GGT) - Grade 3	—	—	—	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 G-Glutamyl Transferase (GGT) - Grade 4	—	—	—	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Glucose, Fasting Serum - Grade 3	—	0 Participants	—	1 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Glucose, Fasting Serum - Grade 4	—	0 Participants	—	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Glucose, Serum - Grade 3	—	—	0 Participants	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Glucose, Serum - Grade 4	—	—	0 Participants	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Hemoglobin - Grade 3	0 Participants	1 Participants	1 Participants	24 Participants	1 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Hemoglobin - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Leukocytes - Grade 3	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Lipase, Total (Colorimetric Assay) - Grade 3	0 Participants	2 Participants	2 Participants	18 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Lipase, Total (Colorimetric Assay) - Grade 4	0 Participants	0 Participants	0 Participants	7 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Lipase, Total (Turbidimetric Assay) - Grade 3	—	—	—	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Lipase, Total (Turbidimetric Assay) - Grade 4	—	—	—	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Lymphocytes (Absolute) - Grade 3	0 Participants	3 Participants	4 Participants	64 Participants	4 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Lymphocytes (Absolute) - Grade 4	0 Participants	0 Participants	0 Participants	9 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Magnesium, Serum - Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Magnesium, Serum - Grade 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Neutrophils (Absolute) - Grade 3	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Neutrophils (Absolute) - Grade 4	—	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 pH, Arterial Blood - Grade 3	—	—	—	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 pH, Arterial Blood - Grade 4	0 Participants	—	—	0 Participants	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Phosphorus, Inorganic - Grade 3	0 Participants	0 Participants	3 Participants	10 Participants	1 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Phosphorus, Inorganic - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Platelet Count - Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Platelet Count - Grade 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Potassium, Serum - Grade 3	0 Participants	0 Participants	0 Participants	6 Participants	0 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Potassium, Serum - Grade 4	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Sodium Serum - Grade 3	0 Participants	1 Participants	1 Participants	26 Participants	1 Participants	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5 Sodium Serum - Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From first dose up to approximately 2.5 years

Population: All treated participants

Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=2 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 n=3 Participants Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Objective Response Rate (ORR)	25.0 Percentage of participants Interval 0.6 to 80.6	37.5 Percentage of participants Interval 15.2 to 64.6	40.0 Percentage of participants Interval 16.3 to 67.7	14.6 Percentage of participants Interval 10.8 to 19.3	50.0 Percentage of participants Interval 1.3 to 98.7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: From first dose up to approximately 2.5 years

Population: All treated participants. Pre-specified for data to be collected only in Part 3.

Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Disease Control Rate (DCR) - Part 3	50.0 Percentage of participants Interval 1.3 to 98.7	33.3 Percentage of participants Interval 0.8 to 90.6	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to the date of the first documented tumor progression as determined or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)

Population: All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Parts 3 and 5.

DOR is defined as the time from the date of first response (CR or PR) to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=1 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Median Duration of Response (mDOR) - Parts 3 and 5	NA weeks Interval 40.0 to 40.0 Insufficient number of participants with events	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first dose of study medication to the date of the first documented objective response (up to approximately 2.5 years)

Population: All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Part 3.

TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=1 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Median Time to Response (mTTR) - Part 3	8.10 Weeks Interval 8.1 to 8.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose until progressive disease (PD) or treatment discontinuation, whichever occurs earlier. (Up to approximately 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Parts 3 and 5.

Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with \>= 50% and \>= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=10 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
The Number of Participants With >=50% or >=80% Tumor Reduction - Parts 3 and 5 WITH >=50% TUMOR REDUCTION	1 Participants	2 Participants	0 Participants	—	—	—	—
The Number of Participants With >=50% or >=80% Tumor Reduction - Parts 3 and 5 WITH >=80% TUMOR REDUCTION	0 Participants	1 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From date of first dose of study medication to the date of death for any cause. (Up to approximately 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Part 3.

Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Overall Survival (OS) - Part 3	NA Years Interval 0.2 to 1.2 Time point at which % of survivors drops below 50% has not been reached due to insufficient number of events and/or follow up	0.3 Years Interval 0.1 to 0.8	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Part 3.

PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Progression Free Survival (PFS) - Part 3	NA Months Interval 1.1 to 11.0 Insufficient number of events	1.6 Months Interval 1.1 to 7.4	—	—	—	—	—

SECONDARY outcome

Timeframe: At 6 months after first dose

Population: All treated participants in Part 3

Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Progression Free Survival Rate (PFSR) at 6 Months - Part 3	50.0 Percentage of participants Interval 0.6 to 91.0	33.3 Percentage of participants Interval 0.9 to 77.4	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Part 3.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Adverse Events (AEs) - Part 3	2 Participants	3 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Part 3.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Serious Adverse Events (SAEs) - Part 3	2 Participants	3 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Part 3.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants. Pre-specified for data to be collected only in Part 3.

The number of participants who died.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
The Number of Participant Deaths in the Study - Part 3	1 Participants	3 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)

Population: All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Part 3.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=2 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Sodium Serum - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Alanine Amino Transferase (ALT) - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Alanine Amino Transferase (ALT) - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Albumin - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Albumin - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Alkaline Phosphatase (ALP) - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Absolute Neutrophil Count - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Absolute Neutrophil Count - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Alkaline Phosphatase (ALP) - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Amylase, Total - Grade 3	1 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Amylase, Total - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Aspartate Aminotransferase (AST) - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Aspartate Aminotransferase (AST) - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Bilirubin, Total - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Bilirubin, Total - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Calcium, Corrected - Grade 3	—	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Calcium, Corrected - Grade 4	—	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Calcium, Ionized - Grade 3	0 Participants	—	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Calcium, Ionized - Grade 4	0 Participants	—	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Calcium, Total - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Calcium, Total - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Creatinine - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Creatinine - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 G-Glutamyl Transferase (GGT) - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Glucose, Fasting Serum - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Glucose, Serum - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Glucose, Serum - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Hemoglobin - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Hemoglobin - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Leukocytes - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Leukocytes - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Lipase, Total (Colorimetric Assay) - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Lipase, Total (Colorimetric Assay) - Grade 4	1 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Lymphocytes (Absolute) - Grade 3	0 Participants	2 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Lymphocytes (Absolute) - Grade 4	1 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Magnesium, Serum - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Magnesium, Serum - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Neutrophils (Absolute) - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Neutrophils (Absolute) - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Phosphorus, Inorganic - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Phosphorus, Inorganic - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Platelet Count - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Platelet Count - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Potassium, Serum - Grade 3	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Potassium, Serum - Grade 4	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3 Sodium Serum - Grade 4	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to 100 days after last dose (up to approximately 126 weeks)

Population: All participants who receive at least 1 dose of drug and have at least 1 ADA sample available. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment Baseline ADA Positive Participant: A participant with baseline ADA positive sample. ADA Positive Participant: Participant with \>=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer \>= 9-fold for Lirilumab and \>= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period. ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=15 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=13 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=255 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=4 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 Baseline ADA Positive - Liri	0 Participants	2 Participants	0 Participants	21 Participants	1 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 ADA Positive - Liri	1 Participants	1 Participants	0 Participants	20 Participants	0 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 ADA Negative - Liri	3 Participants	10 Participants	10 Participants	234 Participants	4 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 Baseline ADA Positive - Nivo	0 Participants	1 Participants	3 Participants	14 Participants	1 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 ADA Positive - Nivo	0 Participants	1 Participants	0 Participants	43 Participants	0 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 ADA Negative - Nivo	4 Participants	14 Participants	13 Participants	212 Participants	3 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 Baseline ADA Positive - Ipi	—	—	—	—	1 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 ADA Positive - Ipi	—	—	—	—	0 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5 ADA Negative - Ipi	—	—	—	—	3 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose Day 1 (Cycles 1 ,3 ,5, 7, 9), Pre-dose Day 29 (Cycle 1, 2)

Population: All treated participants with available archival tumor sample and with pre- and on-treatment biopsies. Pre-specified for data to be collected only in Parts 1, 2, and 5.

The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show \>=1% or \>= 5% PD-L1 expression in the tumor cell membrane and negative if they show \< 1% or \< 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC). PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive. PDL1= programmed cell death ligand 1

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=11 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=13 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=231 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=1 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5 PD-L1 1 percent - positive	2 Number of participants	5 Number of participants	9 Number of participants	127 Number of participants	1 Number of participants	—	—
The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5 PD-L1 1 percent - negative	1 Number of participants	6 Number of participants	4 Number of participants	104 Number of participants	0 Number of participants	—	—
The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5 PD-L1 5 percent - positive	2 Number of participants	4 Number of participants	4 Number of participants	77 Number of participants	0 Number of participants	—	—
The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5 PD-L1 5 percent - negative	1 Number of participants	7 Number of participants	9 Number of participants	154 Number of participants	1 Number of participants	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=13 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=11 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=249 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=2 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5 Cycle 1	2223.10 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 27	6509.35 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 27	22250.96 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 29	52034.18 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 33	65333.91 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 3	—	—
Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5 Cycle 2	2277.39 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 6	7286.95 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 24	25623.89 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 20	69224.70 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 26	81600.00 ng/mL Geometric Coefficient of Variation NA NA = only 1 participant	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=13 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=11 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=249 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=2 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5 Cycle 1	360903.09 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 23	734836.53 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 45	4462883.03 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 35	9647500.52 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 37	8819119.61 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 29	—	—
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5 Cycle 2	569516.79 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 26	1367259.80 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 67	6547184.03 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 37	11731186.91 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 51	9958714.89 hour*ng/mL Geometric Coefficient of Variation NA NA = not applicable, only 1 participant	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=12 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=11 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=209 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=1 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5 Cycle 1	366418.73 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 21	1155363.50 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 33	4462883.03 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 35	11418017.10 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 28	10843715.48 hour*ng/mL Geometric Coefficient of Variation NA NA = not applicable, only 1 participant	—	—
Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5 Cycle 2	569516.79 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 26	1726615.52 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 44	6712959.58 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 31	18504162.18 hour*ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 28	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=13 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=11 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=249 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=2 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5 Cycle 1	1.13 hour Interval 1.0 to 1.3	1.05 hour Interval 0.8 to 21.7	1.07 hour Interval 1.0 to 1.6	1.22 hour Interval 0.1 to 161.3	1.03 hour Interval 1.0 to 1.1	—	—
Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5 Cycle 2	1.08 hour Interval 1.0 to 1.5	1.02 hour Interval 1.0 to 1.6	1.13 hour Interval 0.9 to 25.5	1.18 hour Interval 0.8 to 168.1	1.33 hour Interval 1.33 to 1.33	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=7 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=7 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=94 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Half-life (T-HALF) - Parts 1, 2 and 5	383.96 hour Standard Deviation 235.421	273.89 hour Standard Deviation 234.588	515.07 hour Standard Deviation 361.525	281.31 hour Standard Deviation 237.236	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=6 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=10 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=75 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Clearance Per Time (CLT) - Parts 1, 2 and 5	0.01 liter per hour Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 22	0.01 liter per hour Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 38	0.01 liter per hour Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 35	0.01 liter per hour Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 30	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=12 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=11 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=209 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=1 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5 Cycle 1	87.62 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 77	521.28 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 60	2572.90 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 47	6195.04 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 45	5190.00 ng/mL Geometric Coefficient of Variation NA NA = not applicable, only 1 participant	—	—
Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5 Cycle 2	358.55 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 68	1180.39 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 65	4827.27 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 32	11392.89 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 45	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=13 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=11 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=249 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=2 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri) Cycle 1 Day 1	2223.10 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 27	6434.65 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 28	22250.96 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 29	45163.87 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 38	65333.91 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 3	—	—
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri) Cycle 2 Day 29	2277.39 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 6	7286.95 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 24	25185.06 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 20	65874.20 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 30	81600.00 ng/mL Geometric Coefficient of Variation NA NA = not applicable, only 1 participant	—	—

SECONDARY outcome

Timeframe: Pre-dose on cycle 1 day 29 and Pre-dose and end of infusion on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=3 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=12 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=11 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=200 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=1 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Ctrough - Parts 1, 2 and 5 (Liri) Cycle 1 Day 29	192.29 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 42	521.28 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 60	2572.90 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 47	6195.08 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 45	5190.00 ng/mL Geometric Coefficient of Variation NA NA = not applicable, only 1 participant	—	—
Ctrough - Parts 1, 2 and 5 (Liri) Cycle 2 Day 29	327.50 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 85	1069.84 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 63	4592.95 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 32	10865.91 ng/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 45	19100.00 ng/mL Geometric Coefficient of Variation NA NA = not applicable, only 1 participant	—	—

SECONDARY outcome

Timeframe: Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.

Population: All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=15 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=12 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=253 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=6 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo) Cycle 1 Day 1	63.16 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 31	66.33 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 16	66.16 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 24	52.48 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 25	44.75 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 15	—	—
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo) Cycle 2 Day 29	104.47 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 16	114.89 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 28	116.08 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 17	99.75 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 25	115.37 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 7	—	—

SECONDARY outcome

Timeframe: 336 hours post dose on cycle 1 day 1 (cycle 1 day 15) and pre-dose and end of infusion on cycle 2 day 29.

Population: All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.

Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.

Outcome measures

Outcome measures
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 Participants Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=14 Participants Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 Participants Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=244 Participants Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=4 Participants Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease	Part 3: Liri 240 + Nivo 240 Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Ctrough - Parts 1, 2 and 5 (Nivo) Cycle 1 Day 15	19.15 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 16	20.14 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 24	21.36 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 24	15.81 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 32	17.30 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 19	—	—
Ctrough - Parts 1, 2 and 5 (Nivo) Cycle 2 Day 29	55.67 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 42	62.18 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 38	71.31 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 21	50.07 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 32	62.62 μg/mL Geometric Coefficient of Variation NA NA = Geometric CV not applicable; %CV = 17	—	—

Adverse Events

Part 1/2 Liri 0.1 + Nivo 3

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Part 1/2: Liri 0.3 + Nivo 3

Serious events: 8 serious events

Other events: 16 other events

Deaths: 7 deaths

Part 1/2: Liri 1 + Nivo 3

Serious events: 9 serious events

Other events: 15 other events

Deaths: 5 deaths

Part 1/2: Liri 3 + Nivo 3

Serious events: 205 serious events

Other events: 271 other events

Deaths: 219 deaths

Part 3: PBO + Nivo 240

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Part 3: Liri 240 + Nivo 240

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 5: Liri 3 + Nivo 3 + Ipi 1

Serious events: 7 serious events

Other events: 10 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 participants at risk Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 participants at risk Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 participants at risk Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 participants at risk Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 3: PBO + Nivo 240 n=2 participants at risk Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 3: Liri 240 + Nivo 240 n=3 participants at risk Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 participants at risk Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Lymph node haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Splenic haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Arrhythmia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Atrial flutter	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Cardiac arrest	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Cardiac failure	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Pericardial effusion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Tachycardia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal hernia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Autoimmune pancreatitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Colitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Haematemesis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Nausea	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Salivary gland fistula	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Subileus	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Vomiting	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Adverse drug reaction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Asthenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Complication associated with device	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Face oedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Fatigue	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders General physical health deterioration	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.1% 9/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Hyperthermia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Localised oedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Malaise	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Non-cardiac chest pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Pyrexia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.9% 14/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Secretion discharge	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Sudden death	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Swelling	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Ulcer	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Hepatobiliary disorders Hepatic failure	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Hepatobiliary disorders Hepatic haematoma	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Abdominal wall abscess	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Actinomycosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Bacteraemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Bacterial infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Bronchitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Cellulitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Cellulitis orbital	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Device related infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Escherichia bacteraemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Gastroenteritis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Infective thrombosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Influenza	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Lung abscess	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Osteomyelitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Otitis externa	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Pneumonia	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Pneumonia influenzal	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Psoas abscess	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Sepsis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Septic shock	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Skin infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Staphylococcal bacteraemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Staphylococcal infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Staphylococcal sepsis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Tracheitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Urinary tract infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Device placement issue	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Head injury	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Osteoradionecrosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Overdose	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Vascular procedure complication	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations General physical condition abnormal	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Lipase increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Platelet count decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Weight decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Feeding disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.8% 8/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Malnutrition	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	38.0% 109/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	66.7% 2/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Brain oedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Carotid artery aneurysm	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Central nervous system haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Cerebral haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Coma	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Dizziness	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Embolic stroke	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Haemorrhage intracranial	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Headache	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Hemiparesis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Presyncope	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Syncope	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Tremor	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Product Issues Device dislocation	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Product Issues Device occlusion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Completed suicide	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Mental status changes	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Renal failure	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Reproductive system and breast disorders Uterine polyp	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	8.4% 24/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Immune-mediated pneumonitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Laryngeal dyspnoea	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Aneurysm	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Arterial rupture	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Embolism	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Hypertension	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Hypotension	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Shock	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Shock haemorrhagic	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Thrombosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).

Other adverse events

Other adverse events
Measure	Part 1/2 Liri 0.1 + Nivo 3 n=4 participants at risk Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 0.3 + Nivo 3 n=16 participants at risk Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 1 + Nivo 3 n=15 participants at risk Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 1/2: Liri 3 + Nivo 3 n=287 participants at risk Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.	Part 3: PBO + Nivo 240 n=2 participants at risk Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 3: Liri 240 + Nivo 240 n=3 participants at risk Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.	Part 5: Liri 3 + Nivo 3 + Ipi 1 n=10 participants at risk Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	24.4% 70/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Eosinophilia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Lymph node pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.8% 8/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Cardiac failure	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Palpitations	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Cardiac disorders Tachycardia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.1% 9/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Ear and labyrinth disorders External ear pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Ear and labyrinth disorders Hypoacusis	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Ear and labyrinth disorders Vertigo	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Endocrine disorders Hyperthyroidism	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Endocrine disorders Hypothyroidism	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	8.7% 25/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	66.7% 2/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Cataract	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Cataract nuclear	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Chorioretinal atrophy	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Chorioretinal disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Diplopia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Dry eye	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Eye movement disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Eye pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Lagophthalmos	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Meibomian gland dysfunction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Myopia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Ocular discomfort	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Retinal deposits	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Strabismus	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Swelling of eyelid	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Uveitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Vision blurred	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Visual acuity reduced	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Visual impairment	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Eye disorders Vitreous detachment	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal discomfort	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 3/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.5% 10/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 5/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	8.4% 24/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.1% 9/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Anal haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Colitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Constipation	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	31.2% 5/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.9% 60/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Dental caries	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	46.7% 7/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	23.0% 66/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	30.0% 3/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.6% 19/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.1% 29/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Epigastric discomfort	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Gastritis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.5% 10/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Melaena	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Nausea	50.0% 2/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	46.7% 7/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	21.6% 62/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Odynophagia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Oesophagitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Oral disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Proctalgia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.5% 10/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Toothache	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Gastrointestinal disorders Vomiting	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 5/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	15.0% 43/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Asthenia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	15.0% 43/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Catheter site haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Chills	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	31.2% 5/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.8% 31/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Device related thrombosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Early satiety	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Face oedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.2% 15/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Facial pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Fatigue	75.0% 3/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	37.5% 6/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	46.7% 7/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.2% 144/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	66.7% 2/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	30.0% 3/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Influenza like illness	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 3/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Injection site swelling	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Localised oedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Malaise	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Mass	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Mucosal inflammation	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.9% 17/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Nodule	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Non-cardiac chest pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.1% 9/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Oedema peripheral	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 3/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.1% 29/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.8% 8/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Peripheral swelling	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Pyrexia	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	31.2% 5/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	24.0% 69/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Swelling face	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
General disorders Xerosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Immune system disorders Hypersensitivity	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Immune system disorders Type IV hypersensitivity reaction	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Bacterial vaginosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Bronchitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.8% 11/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Conjunctivitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Ear infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Fungal disease carrier	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Fungal infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Gastroenteritis	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Gastroenteritis viral	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Genital infection fungal	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Hordeolum	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Influenza	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Nasopharyngitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Ophthalmic herpes zoster	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Oral candidiasis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Pneumonia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.6% 16/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Pneumonia influenzal	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Respiratory tract infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Sinusitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Staphylococcal bacteraemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Upper respiratory tract infection	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.3% 18/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Infections and infestations Viral infection	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Incision site pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Infusion related reaction	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	46.7% 7/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	7.7% 22/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Muscle strain	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Sunburn	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Alanine aminotransferase increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Amylase increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.6% 19/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	7.3% 21/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood bilirubin increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood creatinine increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.9% 17/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	30.0% 3/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood magnesium decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood magnesium increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood phosphorus decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood pressure increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Blood testosterone decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations CD4 lymphocytes decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Electrocardiogram QT prolonged	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Electrocardiogram T wave amplitude decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Heart sounds abnormal	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Intraocular pressure increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Lipase increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	7.3% 21/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Lymphocyte count decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Neutrophil count decreased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Prothrombin time ratio increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Transaminases increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Troponin increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Weight decreased	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.6% 39/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	100.0% 3/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Investigations Weight increased	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Decreased appetite	50.0% 2/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	17.4% 50/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.9% 17/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Gout	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	7.3% 21/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.1% 9/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	7.7% 22/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	9.4% 27/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	9.8% 28/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Hypophosphataemia	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.9% 14/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Iron deficiency	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	31.2% 5/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	53.3% 8/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.2% 35/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	30.0% 3/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 3/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	11.8% 34/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.2% 15/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	40.0% 6/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.1% 9/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.2% 15/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.8% 11/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 3/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	9.1% 26/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.8% 8/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.6% 16/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Burning sensation	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Consciousness fluctuating	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Dizziness	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	7.7% 22/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Dysarthria	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Facial paresis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Headache	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	15.3% 44/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Hemiplegia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Lethargy	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Memory impairment	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Migraine	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Myoclonus	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Neuropathy peripheral	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Paraesthesia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 5/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Sciatica	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Sinus headache	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Somnolence	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.5% 10/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Taste disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders VIth nerve paralysis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Nervous system disorders Visual field defect	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Anxiety	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.6% 19/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Confusional state	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.8% 8/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Depressed mood	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Depression	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Hallucination	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Psychiatric disorders Insomnia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	40.0% 6/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.2% 15/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Nephrolithiasis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Nocturia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Pollakiuria	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Renal and urinary disorders Urinary retention	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Reproductive system and breast disorders Breast pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Reproductive system and breast disorders Menstruation irregular	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Reproductive system and breast disorders Uterine polyp	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Reproductive system and breast disorders Vulva cyst	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Reproductive system and breast disorders Vulval disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Cough	50.0% 2/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	56.2% 9/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 5/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	21.6% 62/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.3% 18/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	16.4% 47/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	30.0% 3/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.8% 8/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.5% 10/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Immune-mediated pneumonitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.2% 12/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pharyngeal disorder	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.1% 9/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 3/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.8% 11/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	3.5% 10/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.4% 7/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.2% 12/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	5.9% 17/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Melanocytic hyperplasia	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	2.1% 6/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Papule	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Parapsoriasis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Pruritus	50.0% 2/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	25.0% 4/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	53.3% 8/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	16.7% 48/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	30.0% 3/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Purpura	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	43.8% 7/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	14.6% 42/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	12.5% 2/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.5% 13/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	50.0% 1/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 2/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	26.7% 4/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Scab	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.7% 5/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Embolism	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.35% 1/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Flushing	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	18.8% 3/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.4% 4/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Hot flush	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	13.3% 2/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	1.0% 3/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Hypertension	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	4.9% 14/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Hypotension	25.0% 1/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	20.0% 3/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.6% 19/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	33.3% 1/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	10.0% 1/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Lymphoedema	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.70% 2/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Thrombosis	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.7% 1/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Vascular disorders Varicose vein	0.00% 0/4 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	6.2% 1/16 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/15 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/287 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/2 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/3 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).	0.00% 0/10 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: please email:

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60