Trial Outcomes & Findings for Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002) (NCT NCT03136185)

Last Updated: 2024-01-10

Results Overview

DLT was defined as any one of the following adverse events (AEs) that occured through Day 7 of the Initial Treatment Period (ITP) and was considered by the Investigator to be possibly, probably or definitely related to bomedemstat: * Thrombocytopenia leading to clinically significant sequelae (i.e., a clinically significant bleeding event or the need for prophylactic transfusions) * A clinically significant bleeding event in a participant with a platelet count \>50 x 10\^9/L (50 k/μL) * Any Grade 4 or 5 non-haematologic adverse event * Any Grade 3 non-haematologic adverse event with failure to recover to Grade 2 within 7 days of drug cessation, with the following exceptions: ≥ Grade 3 nausea, vomiting or diarrhea that responds to standard medical care; ≥ Grade 3 aesthenia lasting less than 14 days; any Grade 3 electrolyte abnormality unrelated to the underlying malignancy and persisting greater than 24 hours. The number of participants with a DLT were reported.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Up to Day 7 of the ITP

Results posted on

2024-01-10

Participant Flow

Participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF) were recruited for this study.

Eighteen participants were enrolled in the Phase 1/2a portion of this study and 72 participants were enrolled in the Phase 2b portion of this study.

Participant milestones

Participant milestones
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally every day (qd) for 85 days during the Initial Treatment Period (ITP). Qualifying participants could continue to receive treatment for an additional 169 days during the Additional Treatment Period (ATP) as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Overall Study STARTED	9	3	6	8	5	11	24	11	13
Overall Study Treated	9	3	6	8	5	11	24	11	13
Overall Study Entered Additional Treatment Period (ATP)	6	2	3	3	1	4	17	5	9
Overall Study Completed Initial Treatment Period (ITP)	7	3	4	4	1	4	18	8	10
Overall Study COMPLETED	1	0	0	2	0	3	14	5	7
Overall Study NOT COMPLETED	8	3	6	6	5	8	10	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally every day (qd) for 85 days during the Initial Treatment Period (ITP). Qualifying participants could continue to receive treatment for an additional 169 days during the Additional Treatment Period (ATP) as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Overall Study Adverse Event	0	1	3	1	2	2	5	1	1
Overall Study Death	0	0	0	1	1	0	1	0	0
Overall Study Physician Decision	3	1	1	2	1	2	1	0	1
Overall Study Protocol Defined Disease Progression	0	0	1	0	0	1	0	1	1
Overall Study Withdrawal by Subject	1	0	1	1	1	1	2	3	3
Overall Study Not Reported	4	1	0	1	0	2	1	1	0

Baseline Characteristics

Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=9 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=6 Participants In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=8 Participants In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=5 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=24 Participants In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=13 Participants In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Total n=90 Participants Total of all reporting groups
Age, Continuous	62.6 Years STANDARD_DEVIATION 12.43 • n=5 Participants	74.7 Years STANDARD_DEVIATION 5.51 • n=7 Participants	64.7 Years STANDARD_DEVIATION 6.59 • n=5 Participants	69.6 Years STANDARD_DEVIATION 8.38 • n=4 Participants	64.8 Years STANDARD_DEVIATION 7.46 • n=21 Participants	69.4 Years STANDARD_DEVIATION 14.40 • n=10 Participants	65.2 Years STANDARD_DEVIATION 9.42 • n=115 Participants	66.7 Years STANDARD_DEVIATION 9.27 • n=6 Participants	61.3 Years STANDARD_DEVIATION 12.07 • n=6 Participants	65.7 Years STANDARD_DEVIATION 10.51 • n=64 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	12 Participants n=115 Participants	8 Participants n=6 Participants	4 Participants n=6 Participants	43 Participants n=64 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	12 Participants n=115 Participants	3 Participants n=6 Participants	9 Participants n=6 Participants	47 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	10 Participants n=10 Participants	22 Participants n=115 Participants	11 Participants n=6 Participants	9 Participants n=6 Participants	80 Participants n=64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	4 Participants n=6 Participants	7 Participants n=64 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	10 Participants n=115 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	21 Participants n=64 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=64 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=10 Participants	12 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	59 Participants n=64 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=64 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=64 Participants

PRIMARY outcome

Timeframe: Up to Day 7 of the ITP

Population: All participants receiving at least one dose of bomedemstat were included in the DLT analysis.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=9 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=6 Participants In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=8 Participants In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=5 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=24 Participants In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=13 Participants In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 30 months

Population: All participants receiving at least one dose of bomedemstat were included in the safety analysis.

An AE was any undesirable physical, psychological or behavioral effect experienced by a participant, in conjunction with the use of the drug or biologic, whether or not product-related. This included any untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat until completion of the study. Serious AEs (SAEs) were any AE that resulted in death, life-threatening experience, required or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly, or important medical events. The number of participants with at least one treatment-emergent (TE) SAE was reported for each arm.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=9 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=6 Participants In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=8 Participants In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=5 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=24 Participants In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=13 Participants In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Number of Participants With Serious Adverse Events	4 Participants	2 Participants	5 Participants	4 Participants	4 Participants	7 Participants	12 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to approximately 30 months

Population: All participants receiving at least one dose of bomedemstat were included in the safety analysis.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=9 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=6 Participants In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=8 Participants In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=5 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=24 Participants In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=13 Participants In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Number of Participants With Adverse Events	9 Participants	3 Participants	6 Participants	8 Participants	5 Participants	11 Participants	23 Participants	10 Participants	12 Participants

PRIMARY outcome

Timeframe: Up to approximately 29 months

Population: All participants receiving at least one dose of bomedemstat were included in the safety analysis.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=9 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=6 Participants In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=8 Participants In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=5 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=24 Participants In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=11 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=13 Participants In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Number of Participants That Discontinued Study Treatment Due To AEs	0 Participants	1 Participants	5 Participants	1 Participants	2 Participants	4 Participants	5 Participants	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.

Population: As pre-specified by the PAP, all participants in the Phase 1/2a portion of the study who received bomedemstat and completed a sufficient portion of the study with enough data for the determination of pharmacokinetic parameters were analyzed. For the purposes of the analysis, Phase 1/2a participants were analyzed irrespective of myelofibrosis disorder (PMF, PPV-MF, or PET-MF) per protocol. Phase 2b participants were excluded from this analysis.

Cmax was defined as the maximum observed concentration after administration obtained directly from the concentration time profile. Blood and plasma samples were collected at pre-specified timepoints to calculate Cmax in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=12 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Phase 1/2a Portion: Observed Maximum Concentration (Cmax) of Bomedemstat Plasma	12.63 ng/mL Geometric Coefficient of Variation 104.41	—	—	—	—	—	—	—	—
Phase 1/2a Portion: Observed Maximum Concentration (Cmax) of Bomedemstat Blood	26.27 ng/mL Geometric Coefficient of Variation 66.76	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.

Tmax was defined as the time to maximum concentration after administration obtained by inspection. Blood and plasma samples were collected at pre-specified timepoints to calculate Tmax in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=12 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Phase 1/2a Portion: Time to Maximum Concentration (Tmax) of Bomedemstat Plasma	1.00 hour Interval 0.5 to 2.85	—	—	—	—	—	—	—	—
Phase 1/2a Portion: Time to Maximum Concentration (Tmax) of Bomedemstat Blood	1.05 hour Interval 0.5 to 3.02	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.

AUC0-24 was defined as the area under the concentration versus time curve calculated using the linear trapezoidal rule from the zero time-point to the 24-hour time-point concentration. Blood and plasma samples were collected at pre-specified timepoints to calculate AUC0-24 in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=12 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Phase 1/2a Portion: Area Under the Concentration-time Curve of Bomedemstat From Time 0 to 24 Hours Post-dose (AUC0-24) Plasma	63.90 hour•ng/mL Geometric Coefficient of Variation 68.56	—	—	—	—	—	—	—	—
Phase 1/2a Portion: Area Under the Concentration-time Curve of Bomedemstat From Time 0 to 24 Hours Post-dose (AUC0-24) Blood	265.92 hour•ng/mL Geometric Coefficient of Variation 68.92	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.

Population: As pre-specified by the PAP, only participants in the Phase 1/2a portion of the study who received bomedemstat and completed a sufficient portion of the study with enough data for the determination of pharmacokinetic parameters were analyzed. For the purposes of the analysis, Phase 1/2a participants were analyzed irrespective of myelofibrosis disorder (PMF, PPV-MF, or PET-MF) per protocol. Phase 2b participants were excluded from this analysis.

CL/F was defined as the apparent total clearance of drug after oral administration. Blood and plasma samples were collected at pre-specified timepoints to calculate CL/F in participants of the Phase 1/2a portion of the study. As pre-specified by the protocol and Pharmacokinetic Analysis Plan (PAP), Phase 2b participants were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=12 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Phase 1/2a Portion: Apparent Total Clearance (CL/F) of Bomedemstat After Oral Administration Plasma	12787.43 mL/min Geometric Coefficient of Variation 63.72	—	—	—	—	—	—	—	—
Phase 1/2a Portion: Apparent Total Clearance (CL/F) of Bomedemstat After Oral Administration Blood	3067.57 mL/min Geometric Coefficient of Variation 85.78	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337)

Population: All allocated participants who received at least one dose of treatment and had available spleen volume data.

Change in spleen volume was assessed based on calculated spleen volume (ml) measured by magnetic resonance imaging (MRI), or computerized tomography (CT) scan (where locally permitted) if the participant was not a candidate for MRI from Day 0. Percentage change from baseline in spleen volume was reported at Initial Treatment Period (ITP) Day 84, ITP Day 168, Additional Treatment Period 1 (ATP1) Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337).

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=2 Participants In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=5 Participants In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=3 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=6 Participants In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=17 Participants In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=8 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=8 Participants In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Percentage Change From Baseline in Spleen Volume ITP Day 84 (Study Day 84)	3.3 Percentage Change Interval -50.5 to 57.0	-13.7 Percentage Change Interval -49.6 to 22.2	2.2 Percentage Change Interval -110.3 to 114.8	-9.1 Percentage Change Interval -27.9 to 9.6	-7.2 Percentage Change Interval -80.2 to 65.8	0.3 Percentage Change Interval -32.3 to 32.9	10.0 Percentage Change Interval 1.2 to 18.8	-2.3 Percentage Change Interval -31.5 to 26.9	1.2 Percentage Change Interval -10.9 to 13.2
Percentage Change From Baseline in Spleen Volume ITP Day 168 (Study Day 168)	—	—	—	-23.9 Percentage Change Interval -43.2 to -4.6	-19.6 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	-33.7 Percentage Change Interval -43.8 to -23.6	12.3 Percentage Change Interval -4.1 to 28.6	-15.4 Percentage Change Interval -56.7 to 25.8	-4.4 Percentage Change Interval -20.6 to 11.8
Percentage Change From Baseline in Spleen Volume ATP1 Day 84 (Study Day 253)	—	—	—	—	—	-27.7 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	—	—
Percentage Change From Baseline in Spleen Volume ATP1 Day 168 (Study Day 337)	—	—	—	-36.5 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	-38.9 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	37.4 Percentage Change Interval -55.6 to 130.5	6.0 Percentage Change Interval -302.0 to 313.9	-15.0 Percentage Change Interval -39.0 to 9.0

PRIMARY outcome

Timeframe: Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591)

Population: All allocated participants who received at least one dose of treatment and had available spleen size data.

Change in spleen size was assessed based on spleen palpation (in cm) at each visit. Percentage change from baseline in spleen size was reported at ITP Day 84, ITP Day 168, ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591). As prespecified by the Statistical Analysis Plan, assessments for the Phase 1/2 groups were summarized using visit windowing after the Day 84 visit of the ITP to allow for comparison with the Phase 2b groups at ITP Day 168.

Outcome measures

Outcome measures
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=6 Participants In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 Participants In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=4 Participants In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=3 Participants In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=2 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=6 Participants In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=13 Participants In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=6 Participants In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=5 Participants In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Percentage Change From Baseline in Spleen Size ATP1 Day 168 (Study Day 337)	-19.0 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	—	-27.8 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	-38.9 Percentage Change Interval -180.1 to 102.3	-1.9 Percentage Change Interval -151.0 to 147.3	-38.9 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	-82.4 Percentage Change Interval -117.4 to -47.4
Percentage Change From Baseline in Spleen Size ITP Day 84 (Study Day 84)	-36.5 Percentage Change Interval -68.0 to -5.0	9.6 Percentage Change Interval -95.1 to 114.2	24.1 Percentage Change Interval -79.4 to 127.7	20.7 Percentage Change Interval -132.2 to 173.7	-28.1 Percentage Change Interval -257.8 to 201.6	11.0 Percentage Change Interval -70.7 to 92.7	-34.7 Percentage Change Interval -58.1 to -11.3	-38.2 Percentage Change Interval -53.4 to -23.1	-59.6 Percentage Change Interval -113.4 to -5.7
Percentage Change From Baseline in Spleen Size ITP Day 168 (Study Day 168)	-20.7 Percentage Change Interval -48.3 to 6.9	-39.6 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	116.3 Percentage Change Interval -1794.8 to 2027.4	-27.8 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	-36.1 Percentage Change Interval -212.6 to 140.4	-24.8 Percentage Change Interval -74.2 to 24.5	-28.5 Percentage Change Interval -60.1 to 3.0	-41.2 Percentage Change Interval -102.9 to 20.6
Percentage Change From Baseline in Spleen Size ATP1 Day 84 (Study Day 253)	—	—	—	-27.8 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	-36.1 Percentage Change Interval -212.6 to 140.4	-27.9 Percentage Change Interval -84.8 to 29.0	-50.4 Percentage Change Interval -101.7 to 0.9	-28.4 Percentage Change Interval -97.7 to 40.9
Percentage Change From Baseline in Spleen Size ATP2 Day 84 (Study Day 422)	-4.8 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	—	—	—	-37.5 Percentage Change Interval -196.3 to 121.3	—	-44.4 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—
Percentage Change From Baseline in Spleen Size ATP2 Day 168 (Study Day 506)	—	—	—	—	—	-22.0 Percentage Change 95% confidence intervals could not be calculated for arms with n\<2 participants.	—	—	—
Percentage Change From Baseline in Spleen Size ATP3 Day 84 (Study Day 591)	—	—	—	—	—	-11.1 Percentage Change Interval -152.3 to 130.1	—	—	—

Adverse Events

Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Ph 2b PMF: Bomedemstat 0.5 mg/kg/d

Serious events: 4 serious events

Other events: 8 other events

Deaths: 1 deaths

Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d

Serious events: 4 serious events

Other events: 5 other events

Deaths: 1 deaths

Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

Ph 2b PMF: Bomedemstat 0.6 mg/kg/d

Serious events: 12 serious events

Other events: 23 other events

Deaths: 1 deaths

Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=9 participants at risk In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally every day (qd) for 85 days during the Initial Treatment Period (ITP). Qualifying participants could continue to receive treatment for an additional 169 days during the Additional Treatment Period (ATP) as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 participants at risk In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=6 participants at risk In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=8 participants at risk In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=5 participants at risk In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=11 participants at risk In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=24 participants at risk In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=11 participants at risk In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=13 participants at risk In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	22.2% 2/9 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	22.2% 2/9 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 20 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	45.5% 5/11 • Number of events 26 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	22.2% 2/9 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 17 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 4/8 • Number of events 26 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	63.6% 7/11 • Number of events 25 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	11.1% 1/9 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac failure	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac failure congestive	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Cardiopulmonary failure	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Faecaloma	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Hiatus hernia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 4/24 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Appendicitis perforated	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Atypical pneumonia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	11.1% 1/9 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Clostridium difficile colitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Erysipelas	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis viral	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Lower respiratory tract infection	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Peritonsillar abscess	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Post procedural cellulitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Renal abscess	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Respiratory tract infection	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Septic shock	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Spontaneous bacterial peritonitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Toxic encephalopathy	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	22.2% 2/9 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 4/8 • Number of events 10 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d n=9 participants at risk In the Phase 1/2a portion of the study, PMF participants received 0.25 mg/kg/d bomedemstat orally every day (qd) for 85 days during the Initial Treatment Period (ITP). Qualifying participants could continue to receive treatment for an additional 169 days during the Additional Treatment Period (ATP) as determined by the investigator.	Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d n=3 participants at risk In the Phase 1/2a portion of the study, PPV-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d n=6 participants at risk In the Phase 1/2a portion of the study, PET-MF participants received 0.25 mg/kg/d bomedemstat orally qd for 85 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.5 mg/kg/d n=8 participants at risk In the Phase 2b portion of the study, PMF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d n=5 participants at risk In the Phase 2b portion of the study, PPV-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d n=11 participants at risk In the Phase 2b portion of the study, PET-MF participants received 0.5 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PMF: Bomedemstat 0.6 mg/kg/d n=24 participants at risk In the Phase 2b portion of the study, PMF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d n=11 participants at risk In the Phase 2b portion of the study, PPV-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.	Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d n=13 participants at risk In the Phase 2b portion of the study, PET-MF participants received 0.6 mg/kg/d bomedemstat orally qd for 169 days during the ITP. Qualifying participants could continue to receive treatment for an additional 169 days during the ATP as determined by the investigator.
Investigations Haematocrit increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Heart rate irregular	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations International normalised ratio increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 10 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Odynophagia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Calcium ionised decreased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	77.8% 7/9 • Number of events 23 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	83.3% 5/6 • Number of events 34 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 20 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	60.0% 3/5 • Number of events 8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	45.5% 5/11 • Number of events 26 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.8% 5/24 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukopenia	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 17 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	11.1% 1/9 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	55.6% 5/9 • Number of events 9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 4/6 • Number of events 19 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	87.5% 7/8 • Number of events 29 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	60.0% 3/5 • Number of events 11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	72.7% 8/11 • Number of events 29 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 4/24 • Number of events 11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	54.5% 6/11 • Number of events 30 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	30.8% 4/13 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Aortic valve incompetence	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Bradycardia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac failure congestive	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac valve disease	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Cardiomegaly	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial ischaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Ventricular extrasystoles	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Ear pain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Blepharitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Conjunctival haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Eye oedema	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Ocular hyperaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Photophobia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Photopsia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Vision blurred	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal mass	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 16 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	33.3% 3/9 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	54.5% 6/11 • Number of events 8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 4/24 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	44.4% 4/9 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	83.3% 5/6 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	36.4% 4/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	37.5% 9/24 • Number of events 12 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Eructation	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haematochezia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Lip haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Lip ulceration	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Mouth ulceration	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	62.5% 5/8 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	29.2% 7/24 • Number of events 9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oral mucosal blistering	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oral pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Tongue discolouration	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Hepatobiliary disorders Biliary colic	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	11.1% 1/9 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Clostridium difficile colitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Conjunctivitis	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Cystitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Erysipelas	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Furuncle	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Gingivitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Herpes zoster	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Lower respiratory tract infection	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Nasal herpes	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Onychomycosis	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Oral herpes	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Rash pustular	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Skin infection	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Subcutaneous abscess	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Infections and infestations Viral pericarditis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	36.4% 4/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Muscle strain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Periorbital haemorrhage	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural swelling	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blast cell count increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood calcium decreased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood creatinine increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood glucose increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood phosphorus decreased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood potassium decreased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood sodium decreased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood uric acid increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Body temperature increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Cardiac murmur	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Prothrombin time prolonged	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Troponin T increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Weight decreased	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	11.1% 1/9 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	36.4% 4/11 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Gout	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypermagnesaemia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Increased appetite	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	44.4% 4/9 • Number of events 8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.8% 5/24 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	36.4% 4/11 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	22.2% 2/9 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Amnesia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	66.7% 6/9 • Number of events 7 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	36.4% 4/11 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 6/24 • Number of events 8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	38.5% 5/13 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Hypersomnia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Lethargy	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Migraine	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Nerve compression	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Neuralgia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Parkinson's disease	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Parosmia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Peroneal nerve palsy	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Presyncope	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Sciatica	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Sinus headache	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Confusional state	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Delirium	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Dysphoria	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Flat affect	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Phonophobia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Sleep disorder	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Sleep terror	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Suicidal ideation	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Chronic kidney disease	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Nocturia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/14 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Proteinuria	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Genital rash	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Diaphragmalgia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	15.4% 2/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rales	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	22.2% 2/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Granulomatous dermatitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperkeratosis	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Koilonychia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Onychalgia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	22.2% 2/9 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	60.0% 3/5 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 23 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash macular	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Vascular disorders Haematoma	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Vascular disorders Hot flush	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Vascular disorders Orthostatic hypotension	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Vascular disorders Pallor	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Chest discomfort	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Early satiety	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Fatigue	55.6% 5/9 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 3/6 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	40.0% 2/5 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	8.3% 2/24 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 26 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Generalised oedema	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Hypothermia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	22.2% 2/9 • Number of events 4 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	50.0% 4/8 • Number of events 10 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	60.0% 3/5 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 4/24 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	23.1% 3/13 • Number of events 5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Pain	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Peripheral swelling	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Pyrexia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	36.4% 4/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Temperature intolerance	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Thirst	11.1% 1/9 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	12.5% 3/24 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Stress cardiomyopathy	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	11.1% 1/9 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Lacrimation increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Eye disorders Vitreous haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal hernia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Anal pruritus	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Anal ulcer	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Lip swelling	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
General disorders Chest pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood albumin decreased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood magnesium decreased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Balance disorder	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Burning sensation	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Catathrenia	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Disturbance in attention	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Drooling	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	27.3% 3/11 • Number of events 3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary retention	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Renal and urinary disorders Urine abnormality	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	18.2% 2/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Breast pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Pelvic pain	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Uterine mass	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hyperactive pharyngeal reflex	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	4.2% 1/24 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 2 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.
Vascular disorders Aortic arteriosclerosis	0.00% 0/9 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/3 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/24 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	9.1% 1/11 • Number of events 1 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to approximately 30 months All-Cause Mortality table includes all allocated participants. Serious and Non-serious adverse events (AEs) tables include all allocated participants who received at least 1 dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor will actively pursue publication of the results of the study in cooperation with the Lead Investigators subject to the terms and conditions of the clinical trial agreement between the Sponsor and Investigators. The Lead/Coordinating Investigator will have the right to submit for publication any results arising from the study subject to the terms and conditions of the Clinical Trial and Confidentiality Disclosure Agreements and the agreement of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER