Trial Outcomes & Findings for A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel (NCT NCT03766581)

NCT ID: NCT03766581

Last Updated: 2023-06-12

Results Overview

Model based assessment estimate for composite event is a customized statistical analysis called MCP-MOD (Multiple Comparison Procedures, MODel) estimation, which is used to check for dose-response relationship. 95% confidence interval (CI) for composite event based on bootstrap (10000 samples).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 2366 participants
• Primary outcome timeframe: From randomization to up to 90 days after randomization
• Results posted on: 2023-06-12

Participant Flow

Participant milestones

Measure	Placebo Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Randomization STARTED	691	328	318	328	310	351	22	18
Randomization COMPLETED	682	324	313	325	306	345	22	17
Randomization NOT COMPLETED	9	4	5	3	4	6	0	1
Treatment STARTED	682	325	313	325	306	344	22	17
Treatment COMPLETED	529	260	242	251	230	240	15	14
Treatment NOT COMPLETED	153	65	71	74	76	104	7	3

Reasons for withdrawal

Measure	Placebo Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Randomization Other reasons	2	1	0	1	0	0	0	0
Randomization Participant no longer meets study criteria	5	3	4	0	2	3	0	1
Randomization Participant request to discontinue study treatment	1	0	0	0	1	2	0	0
Randomization Participant withdrew consent	1	0	1	2	1	1	0	0
Treatment Adverse Event	82	44	47	46	50	77	5	2
Treatment Participant request to discontinue treatment	34	6	10	10	14	15	0	1
Treatment Participant withdrew consent	11	4	5	5	4	4	0	0
Treatment Death	1	0	0	0	0	0	0	0
Treatment Lost to Follow-up	1	0	0	1	0	0	0	0
Treatment Poor/Non compliance	2	2	1	1	1	1	0	0
Treatment Participant no longer meets study criteria	9	1	5	4	4	4	2	0
Treatment Other reasons	13	8	3	7	3	3	0	0

Baseline Characteristics

A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel

Baseline characteristics by cohort

Measure	Placebo n=691 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=328 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=318 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=328 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=310 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=351 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=18 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Total n=2366 Participants Total of all reporting groups
Age, Continuous	69.1 Years STANDARD_DEVIATION 10.58 • n=5 Participants	70.9 Years STANDARD_DEVIATION 10.66 • n=7 Participants	70.1 Years STANDARD_DEVIATION 11.34 • n=5 Participants	69.3 Years STANDARD_DEVIATION 10.69 • n=4 Participants	69.7 Years STANDARD_DEVIATION 10.59 • n=21 Participants	69.5 Years STANDARD_DEVIATION 11.11 • n=8 Participants	65.7 Years STANDARD_DEVIATION 10.64 • n=8 Participants	65.4 Years STANDARD_DEVIATION 11.65 • n=24 Participants	69.6 Years STANDARD_DEVIATION 10.81 • n=42 Participants
Sex: Female, Male Female	254 Participants n=5 Participants	109 Participants n=7 Participants	118 Participants n=5 Participants	121 Participants n=4 Participants	112 Participants n=21 Participants	128 Participants n=8 Participants	7 Participants n=8 Participants	10 Participants n=24 Participants	859 Participants n=42 Participants
Sex: Female, Male Male	437 Participants n=5 Participants	219 Participants n=7 Participants	200 Participants n=5 Participants	207 Participants n=4 Participants	198 Participants n=21 Participants	223 Participants n=8 Participants	15 Participants n=8 Participants	8 Participants n=24 Participants	1507 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	22 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	23 Participants n=4 Participants	29 Participants n=21 Participants	27 Participants n=8 Participants	7 Participants n=8 Participants	7 Participants n=24 Participants	197 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	619 Participants n=5 Participants	304 Participants n=7 Participants	294 Participants n=5 Participants	304 Participants n=4 Participants	279 Participants n=21 Participants	323 Participants n=8 Participants	14 Participants n=8 Participants	10 Participants n=24 Participants	2147 Participants n=42 Participants
Race/Ethnicity, Customized White	549 Participants n=5 Participants	257 Participants n=7 Participants	246 Participants n=5 Participants	260 Participants n=4 Participants	251 Participants n=21 Participants	288 Participants n=8 Participants	18 Participants n=8 Participants	15 Participants n=24 Participants	1884 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	15 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	48 Participants n=42 Participants
Race/Ethnicity, Customized Asian	35 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants	13 Participants n=4 Participants	11 Participants n=21 Participants	17 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	109 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Asian Indian	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	6 Participants n=42 Participants
Race/Ethnicity, Customized Chinese	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Japanese	84 Participants n=5 Participants	46 Participants n=7 Participants	40 Participants n=5 Participants	41 Participants n=4 Participants	39 Participants n=21 Participants	40 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	290 Participants n=42 Participants
Race/Ethnicity, Customized Malay	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Asian Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	24 Participants n=42 Participants

PRIMARY outcome

Timeframe: From randomization to up to 90 days after randomization

Population: All randomized participants who experienced a new ischemic stroke by day 90, or an evaluable day 90 MRI regardless of when the MRI was collected. Dose -response model-based endpoint that was pre-specified for data to be collected only in the Placebo, 25 mg QD, and BID dose regimens.

Model based assessment estimate for composite event is a customized statistical analysis called MCP-MOD (Multiple Comparison Procedures, MODel) estimation, which is used to check for dose-response relationship. 95% confidence interval (CI) for composite event based on bootstrap (10000 samples).

Outcome measures

Measure	Placebo n=625 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=308 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=287 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=277 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=317 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90	16.8 Percentage of participants Interval 14.2 to 19.4	16.7 Percentage of participants Interval 14.4 to 19.0	16.6 Percentage of participants Interval 14.5 to 18.7	15.6 Percentage of participants Interval 13.6 to 17.9	15.4 Percentage of participants Interval 13.0 to 18.0	15.3 Percentage of participants Interval 12.3 to 20.4	—	—

SECONDARY outcome

Timeframe: From first dose to up to 107 days after first dose

Population: All treated participants

Percent of participants with major bleeding based on the Bleeding Academic Research Consortium (BARC) Types 3 and 5 definitions. BARC bleeding types:

3a = Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL transfusion with overt bleeding 3b = Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3c = Intracranial hemorrhage, 5a = Probable fatal bleeding 5b = Definite fatal bleeding

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Percent of Participants With Major Bleeding According to BARC Type 3 and 5	0.6 Percentage of participants Interval 0.2 to 1.5	0.6 Percentage of participants Interval 0.1 to 2.2	0.6 Percentage of participants Interval 0.1 to 2.3	1.5 Percentage of participants Interval 0.5 to 3.6	1.6 Percentage of participants Interval 0.5 to 3.8	1.5 Percentage of participants Interval 0.5 to 3.4	0 Percentage of participants Interval 0.0 to 15.4	0 Percentage of participants Interval 0.0 to 19.5

SECONDARY outcome

Timeframe: From first dose to up to 107 days after first dose

Population: All treated participants

Number of participants with bleeding based on Bleeding Academic Research Consortium (BARC) Type 1 to 5. BARC bleeding types: 0=No bleeding. 1=Not actionable bleeding. 2=Overt, actionable sign of hemorrhage requiring nonsurgical, medical intervention by a health-care professional, leading to hospitalization or increased level of care, or prompting evaluation. 3a=Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL. 3b=Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring IV vasoactive agents. 3c=Intracranial hemorrhage; intraocular bleed compromising vision. 4=CABG-related bleeding, perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy to control bleeding, transfusion of ≥5 U whole blood or packed red blood cells within a 48-hour period, chest tube output more than or equal to 2L within a 24-hour period. 5a=Probable fatal bleeding. 5b=Definite fatal bleeding.

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Bleeding Based on BARC Types 1-5 Type 1	41 Participants	26 Participants	16 Participants	28 Participants	25 Participants	22 Participants	5 Participants	2 Participants
Number of Participants With Bleeding Based on BARC Types 1-5 Type 2	9 Participants	7 Participants	9 Participants	7 Participants	10 Participants	8 Participants	1 Participants	1 Participants
Number of Participants With Bleeding Based on BARC Types 1-5 Type 3A	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on BARC Types 1-5 Type 3B	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on BARC Types 1-5 Type 3C	2 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on BARC Types 1-5 Type 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on BARC Types 1-5 Type 5A	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on BARC Types 1-5 Type 5B	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to up to 107 days after first dose

Population: All treated participants

Number of participants with bleeding based on International Society on Thrombosis and Hemostasis (ISTH). ISTH Bleeding Types: 1) Fatal bleeding and/or 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome and/or 3) Bleeding causing a fall in hemoglobin level of ≥2 g/dL, or leading to transfusion of ≥2 units of whole blood or red cells.

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Bleeding Based on ISTH-Defined Criteria Major	4 Participants	2 Participants	2 Participants	5 Participants	6 Participants	5 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on ISTH-Defined Criteria Clinically Relevant Non-Major (CRNM)	7 Participants	8 Participants	9 Participants	7 Participants	8 Participants	8 Participants	1 Participants	1 Participants
Number of Participants With Bleeding Based on ISTH-Defined Criteria Major or CRNM	11 Participants	10 Participants	11 Participants	12 Participants	14 Participants	13 Participants	1 Participants	1 Participants
Number of Participants With Bleeding Based on ISTH-Defined Criteria Minor Bleed	43 Participants	25 Participants	16 Participants	28 Participants	26 Participants	22 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose to up to 107 days after first dose

Population: All treated participants

Number of participants with bleeding based on Platelet Inhibition and Patient Outcomes (PLATO) defined criteria. PLATO bleeding definitions:

1. Major Life-threatening: Fatal, Intracranial, Intrapericardial with cardiac tamponade, Resulting in hypovolemic shock or severe hypotension that requires pressors or surgery, Clinically overt or apparent bleeding associated with decrease in hemoglobin >5 g/dL, Requiring transfusion of ≥4 U whole blood or packed red blood cells (PRBCs)

2. Other Major: Significantly disabling (eg, intraocular with permanent vision loss), Associated drop in hemoglobin of 3 to 5 g/dL, Requiring transfusion of 2 to 3 U whole blood or PRBCs

3. Any Major: Any one of the above criteria

4. Minor: Bleeding that does not meet criteria for PLATO Major bleeding, and requiring medical intervention

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Bleeding Based on PLATO-Defined Criteria MAJOR LIFE-THREATENING	2 Participants	1 Participants	1 Participants	4 Participants	3 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on PLATO-Defined Criteria OTHER MAJOR BLEEDING	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on PLATO-Defined Criteria ANY MAJOR	4 Participants	2 Participants	2 Participants	5 Participants	5 Participants	5 Participants	0 Participants	0 Participants
Number of Participants With Bleeding Based on PLATO-Defined Criteria MINOR	7 Participants	6 Participants	7 Participants	7 Participants	9 Participants	9 Participants	0 Participants	1 Participants
Number of Participants With Bleeding Based on PLATO-Defined Criteria MINIMAL	43 Participants	27 Participants	18 Participants	28 Participants	26 Participants	21 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: From randomization to up to 90 days after randomization

Population: All randomized participants who experienced a new ischemic stroke by day 90, or an evaluable day 90 MRI regardless of when the MRI was collected.

Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90.

Outcome measures

Measure	Placebo n=625 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=308 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=287 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=277 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=317 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=21 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=16 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Percent of Participants With Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90	16.6 Percentage of participants	16.2 Percentage of participants	18.5 Percentage of participants	14.1 Percentage of participants	14.8 Percentage of participants	16.4 Percentage of participants	19.0 Percentage of participants	18.8 Percentage of participants

SECONDARY outcome

Timeframe: From randomization to up to 90 days after randomization

Population: All randomized participants

Composite of percent of participants of new ischemic stroke, (Myocardial Infarction) MI and all cause death.

Outcome measures

Measure	Placebo n=691 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=328 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=318 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=328 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=310 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=351 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=18 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death	6.1 Percentage of participants Interval 4.3 to 7.9	5.2 Percentage of participants Interval 2.8 to 7.6	4.7 Percentage of participants Interval 2.4 to 7.0	4.9 Percentage of participants Interval 2.5 to 7.2	5.2 Percentage of participants Interval 2.7 to 7.6	9.4 Percentage of participants Interval 6.3 to 12.5	18.2 Percentage of participants Interval 2.1 to 34.3	5.6 Percentage of participants Interval 0.0 to 16.1

SECONDARY outcome

Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

Population: All randomized participants with a complete NIHSS assessment

The NIHSS is an 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke participant is.

Outcome measures

Measure	Placebo n=684 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=324 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=311 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=326 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=305 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=348 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
National Institutes of Health Stroke Scale (NIHSS) Baseline	1.6 Score on a scale Standard Deviation 1.87	1.7 Score on a scale Standard Deviation 1.68	1.6 Score on a scale Standard Deviation 1.73	1.6 Score on a scale Standard Deviation 1.79	1.8 Score on a scale Standard Deviation 1.81	1.6 Score on a scale Standard Deviation 1.79	1.1 Score on a scale Standard Deviation 1.44	2.0 Score on a scale Standard Deviation 1.70
National Institutes of Health Stroke Scale (NIHSS) Day 21	0.9 Score on a scale Standard Deviation 2.11	0.8 Score on a scale Standard Deviation 1.35	0.8 Score on a scale Standard Deviation 1.43	0.8 Score on a scale Standard Deviation 1.58	0.8 Score on a scale Standard Deviation 1.48	0.9 Score on a scale Standard Deviation 1.88	0.8 Score on a scale Standard Deviation 1.90	0.9 Score on a scale Standard Deviation 1.39
National Institutes of Health Stroke Scale (NIHSS) Day 90	0.5 Score on a scale Standard Deviation 1.40	0.6 Score on a scale Standard Deviation 1.06	0.6 Score on a scale Standard Deviation 1.51	0.6 Score on a scale Standard Deviation 1.14	0.6 Score on a scale Standard Deviation 1.32	0.6 Score on a scale Standard Deviation 1.29	0.3 Score on a scale Standard Deviation 0.72	0.6 Score on a scale Standard Deviation 1.45
National Institutes of Health Stroke Scale (NIHSS) First recurrent stroke	6.2 Score on a scale Standard Deviation 5.01	4.6 Score on a scale Standard Deviation 6.79	5.4 Score on a scale Standard Deviation 3.17	4.6 Score on a scale Standard Deviation 4.30	7.1 Score on a scale Standard Deviation 4.68	4.4 Score on a scale Standard Deviation 4.60	5.3 Score on a scale Standard Deviation 3.06	1.0 Score on a scale Standard Deviation NA Insufficient number of participants with events

SECONDARY outcome

Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

Population: All randomized participants with a complete mRS assessment

The Modified Rankin Score (mRS) is a 6-point disability scale with possible scores ranging from 0 to 6.

0 = No symptoms at all

1. = No significant disability despite symptoms; able to carry out all usual duties and activities

2. = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

3. = Moderate disability; requiring some help, but able to walk without assistance

4. = Moderately severe disability; unable to walk and attend to bodily needs without assistance

5. = Severe disability; bedridden, incontinent and requiring constant nursing care and attention

6. = Dead

Outcome measures

Measure	Placebo n=688 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=326 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=314 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=328 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=309 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=349 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Modified Rankin Scale (mRS) Baseline	0.5 Score on a scale Standard Deviation 0.87	0.6 Score on a scale Standard Deviation 0.95	0.6 Score on a scale Standard Deviation 0.96	0.5 Score on a scale Standard Deviation 0.86	0.5 Score on a scale Standard Deviation 0.89	0.6 Score on a scale Standard Deviation 0.95	0.2 Score on a scale Standard Deviation 0.53	0.7 Score on a scale Standard Deviation 0.99
Modified Rankin Scale (mRS) Day 21	1.0 Score on a scale Standard Deviation 1.18	1.0 Score on a scale Standard Deviation 1.13	0.9 Score on a scale Standard Deviation 1.15	0.9 Score on a scale Standard Deviation 1.15	1.0 Score on a scale Standard Deviation 1.17	0.9 Score on a scale Standard Deviation 1.19	0.9 Score on a scale Standard Deviation 1.27	1.3 Score on a scale Standard Deviation 1.14
Modified Rankin Scale (mRS) Day 90	0.7 Score on a scale Standard Deviation 1.04	0.8 Score on a scale Standard Deviation 1.04	0.8 Score on a scale Standard Deviation 1.07	0.7 Score on a scale Standard Deviation 1.01	0.7 Score on a scale Standard Deviation 1.01	0.8 Score on a scale Standard Deviation 1.05	0.6 Score on a scale Standard Deviation 1.05	1.0 Score on a scale Standard Deviation 1.11
Modified Rankin Scale (mRS) First recurrent stroke	3.0 Score on a scale Standard Deviation 1.60	2.7 Score on a scale Standard Deviation 1.03	2.6 Score on a scale Standard Deviation 1.35	2.3 Score on a scale Standard Deviation 1.62	2.9 Score on a scale Standard Deviation 1.64	1.8 Score on a scale Standard Deviation 1.72	2.0 Score on a scale Standard Deviation 0.00	1.0 Score on a scale Standard Deviation NA Insufficient number of participants with events

SECONDARY outcome

Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

Population: All randomized participants with a complete MoCA assessment

The Montreal Cognitive Assessment (MoCA) is a survey with a summed score. MoCA score ranges between a lowest score of 0 to a highest score of 30. A score of:

• ≥26 points: indicates normal cognitive function
• 18-25 points: Mild cognitive impairment
• 10-17 points: Moderate cognitive impairment
• fewer than 10 points: Severe cognitive impairment

Outcome measures

Measure	Placebo n=541 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=257 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=235 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=257 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=235 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=276 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=14 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Montreal Cognitive Assessment (MoCA) Baseline	22.3 Score on a scale Standard Deviation 5.06	21.6 Score on a scale Standard Deviation 5.59	22.0 Score on a scale Standard Deviation 5.18	22.5 Score on a scale Standard Deviation 4.82	22.4 Score on a scale Standard Deviation 5.04	22.1 Score on a scale Standard Deviation 5.31	24.4 Score on a scale Standard Deviation 3.84	22.0 Score on a scale Standard Deviation 4.59
Montreal Cognitive Assessment (MoCA) Day 21	24.0 Score on a scale Standard Deviation 4.77	23.9 Score on a scale Standard Deviation 5.01	24.0 Score on a scale Standard Deviation 4.70	24.3 Score on a scale Standard Deviation 4.57	23.6 Score on a scale Standard Deviation 4.48	24.0 Score on a scale Standard Deviation 4.96	26.4 Score on a scale Standard Deviation 2.61	24.1 Score on a scale Standard Deviation 4.70
Montreal Cognitive Assessment (MoCA) Day 90	24.6 Score on a scale Standard Deviation 4.54	24.0 Score on a scale Standard Deviation 4.69	24.2 Score on a scale Standard Deviation 4.80	24.4 Score on a scale Standard Deviation 4.48	24.5 Score on a scale Standard Deviation 4.36	24.2 Score on a scale Standard Deviation 5.05	25.0 Score on a scale Standard Deviation 4.72	26.4 Score on a scale Standard Deviation 1.69
Montreal Cognitive Assessment (MoCA) First recurrent stroke	23.2 Score on a scale Standard Deviation 6.63	17.3 Score on a scale Standard Deviation 6.11	25.3 Score on a scale Standard Deviation 2.31	19.0 Score on a scale Standard Deviation 8.49	3.0 Score on a scale Standard Deviation NA Insufficient number of participants with events	23.1 Score on a scale Standard Deviation 7.08	11.0 Score on a scale Standard Deviation NA Insufficient number of participants with events	22.0 Score on a scale Standard Deviation NA Insufficient number of participants with events

SECONDARY outcome

Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

Population: All randomized participants with a complete DSST assessment

The Descriptive Summary of the Digit Symbol Substitution Test (DSST) is a scale item, with a lowest score of 0 and highest total score of 135. Higher score indicates better cognitive functioning.

Outcome measures

Measure	Placebo n=493 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=238 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=209 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=234 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=220 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=257 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=14 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Digit Symbol Substitution Test (DSST) Baseline	34.9 Score on a scale Standard Deviation 22.36	31.2 Score on a scale Standard Deviation 18.87	32.9 Score on a scale Standard Deviation 22.89	37.2 Score on a scale Standard Deviation 25.67	33.7 Score on a scale Standard Deviation 21.89	31.7 Score on a scale Standard Deviation 19.15	47.1 Score on a scale Standard Deviation 29.34	29.2 Score on a scale Standard Deviation 18.16
Digit Symbol Substitution Test (DSST) Day 21	41.2 Score on a scale Standard Deviation 22.14	38.9 Score on a scale Standard Deviation 19.27	40.2 Score on a scale Standard Deviation 21.60	45.1 Score on a scale Standard Deviation 25.77	41.2 Score on a scale Standard Deviation 22.87	39.1 Score on a scale Standard Deviation 21.35	54.6 Score on a scale Standard Deviation 32.73	37.1 Score on a scale Standard Deviation 20.13
Digit Symbol Substitution Test (DSST) Day 90	42.8 Score on a scale Standard Deviation 21.18	41.7 Score on a scale Standard Deviation 21.66	41.3 Score on a scale Standard Deviation 20.29	45.2 Score on a scale Standard Deviation 21.86	45.5 Score on a scale Standard Deviation 23.44	41.4 Score on a scale Standard Deviation 21.97	47.5 Score on a scale Standard Deviation 27.48	40.7 Score on a scale Standard Deviation 17.46
Digit Symbol Substitution Test (DSST) First recurrent stroke	36.3 Score on a scale Standard Deviation 13.56	28.0 Score on a scale Standard Deviation 20.95	42.0 Score on a scale Standard Deviation 4.36	40.5 Score on a scale Standard Deviation 2.12	23.0 Score on a scale Standard Deviation NA Insufficient number of participants with events	27.5 Score on a scale Standard Deviation 16.96	9.0 Score on a scale Standard Deviation NA Insufficient number of participants with events	47.0 Score on a scale Standard Deviation NA Insufficient number of participants with events

SECONDARY outcome

Timeframe: From first dose to 2 days after last dose of study therapy (up to approximately 107 days)

Population: All treated participants

AE: include all non-serious adverse events with onset on or after first dose date and within 2 days after the last dose of study treatment.

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Adverse Events (AEs)	399 Participants	190 Participants	186 Participants	192 Participants	193 Participants	211 Participants	11 Participants	13 Participants

SECONDARY outcome

Timeframe: From first dose to up to 90 days after first dose

Population: All treated participants

Number of participants with clinically significant vital sign abnormalities. Vital signs included heart rate and diastolic and systolic blood pressure.

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Clinically Significant Vital Sign Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to up to 90 days after first dose

Population: All treated participants

Number of participants with clinically significant physical examination abnormalities.

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Clinically Significant Physical Examination Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to up to 90 days after first dose

Population: All treated participants

Number of participants with clinically significant ECG abnormalities.

Outcome measures

Measure	Placebo n=682 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to up to approximately 38 months

Population: All treated participants with at least one clinically significant liver laboratory abnormality

The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.

Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)

Outcome measures

Measure	Placebo n=642 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=303 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=280 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=306 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=281 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=324 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=21 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=16 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver ALT > 3x ULN	4 Participants	2 Participants	0 Participants	2 Participants	3 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver ALT > 5x ULN	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver ALT > 10x ULN	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver ALT > 20x ULN	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver AST > 3x ULN	6 Participants	5 Participants	1 Participants	4 Participants	3 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver AST > 5x ULN	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver AST > 10x ULN	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver AST > 20x ULN	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver ALP > 2x ULN	4 Participants	5 Participants	1 Participants	6 Participants	4 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver Total Bilirubin > 1.5x ULN	10 Participants	6 Participants	2 Participants	7 Participants	5 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver Total Bilirubin > 2x ULN	3 Participants	1 Participants	1 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver Concurrent ALT/AST Elevation > 3x ULN with total bilirubin >2x ULN	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and day 90

Population: All participants with at least one aPTT pharmacodynamic endpoint assessed after first dose

Percent change from baseline in activated partial thromboplastin time (aPTT) activity via exposure response.

Outcome measures

Measure	Placebo n=503 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=251 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=226 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=241 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=214 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=232 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=14 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=14 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Percent Change From Baseline in aPTT Activity	2.47 Percent change Standard Error 0.768	38.72 Percent change Standard Error 2.264	58.30 Percent change Standard Error 3.195	97.32 Percent change Standard Error 3.601	140.76 Percent change Standard Error 5.154	193.64 Percent change Standard Error 7.041	48.48 Percent change Standard Error 11.243	118.06 Percent change Standard Error 13.840

SECONDARY outcome

Timeframe: Baseline and day 90

Population: All participants with at least one factor XI clotting pharmacodynamic endpoint assessed after first dose

Percent change from baseline in factor XI clotting activity via exposure response.

Outcome measures

Measure	Placebo n=503 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=251 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=223 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=228 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=216 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=236 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=15 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=13 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Percent Change From Baseline in Factor XI Clotting Activity	4.48 Percent change Standard Error 3.455	-8.88 Percent change Standard Error 1.280	-17.67 Percent change Standard Error 1.900	-37.20 Percent change Standard Error 1.655	-61.52 Percent change Standard Error 1.869	-70.25 Percent change Standard Error 3.043	3.86 Percent change Standard Error 13.754	-44.27 Percent change Standard Error 6.501

SECONDARY outcome

Timeframe: From first dose to up to 90 days after first dose

Population: All treated participants with at least one post-dose PK sample. Pre-specified for data to be collected only in the 25 mg QD, and BID dose regimens.

Pharmacokinetic Parameter - Estimated Clearance (CL). CL is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.

Outcome measures

Measure	Placebo n=323 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=307 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=323 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=303 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=341 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Pharmacokinetic Parameter - Estimated Clearance (CL)	8.15 L/h Geometric Coefficient of Variation 34	8.01 L/h Geometric Coefficient of Variation 34.3	7.54 L/h Geometric Coefficient of Variation 32.8	7.08 L/h Geometric Coefficient of Variation 31.3	7.43 L/h Geometric Coefficient of Variation 32.9	—	—	—

SECONDARY outcome

Timeframe: From first dose to up to 90 days after first dose

Population: All treated participants with at least one post-dose PK sample. Pre-specified for data to be collected only in the 25 mg QD, and BID dose regimens.

Pharmacokinetic Parameter - Volume of the Central Compartment (VC). VC is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.

Outcome measures

Measure	Placebo n=323 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=307 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=323 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=303 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=341 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Pharmacokinetic Parameter - Volume of the Central Compartment (VC)	34.9 L Geometric Coefficient of Variation 152	31.4 L Geometric Coefficient of Variation 138	30.9 L Geometric Coefficient of Variation 145	28.9 L Geometric Coefficient of Variation 149	31.6 L Geometric Coefficient of Variation 181	—	—	—

SECONDARY outcome

Timeframe: At day 90

Population: All randomized participants with an evaluable MRI

Total volume of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.

Outcome measures

Measure	Placebo n=82 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=40 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=49 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=36 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=35 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=35 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=3 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=3 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI	2.3492 mL Standard Deviation 11.40906	0.8976 mL Standard Deviation 1.96342	2.9902 mL Standard Deviation 8.28993	1.2682 mL Standard Deviation 2.72452	1.4727 mL Standard Deviation 3.78795	1.2711 mL Standard Deviation 4.05035	8.8960 mL Standard Deviation 13.85294	1.4503 mL Standard Deviation 1.89112

SECONDARY outcome

Timeframe: At day 90

Population: All randomized participants with an evaluable MRI

Number of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.

Outcome measures

Measure	Placebo n=82 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=40 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=49 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=36 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=35 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=35 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=3 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=3 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI >0	82 Participants	40 Participants	49 Participants	36 Participants	35 Participants	35 Participants	3 Participants	3 Participants
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI 1	57 Participants	26 Participants	36 Participants	26 Participants	24 Participants	23 Participants	1 Participants	2 Participants
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI 2	11 Participants	8 Participants	5 Participants	5 Participants	3 Participants	6 Participants	2 Participants	0 Participants
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI 3	8 Participants	5 Participants	4 Participants	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI 4	1 Participants	1 Participants	2 Participants	3 Participants	2 Participants	2 Participants	0 Participants	1 Participants
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI 5	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI >5	4 Participants	0 Participants	2 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to up to 90 days after randomization

Population: All randomized participants

Secondary analysis of symptomatic ischemic stroke events. Clinical events are included up to day 90. Wald 95% CI within group. Undetermined stroke is included.

Outcome measures

Measure	Placebo n=691 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=328 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=318 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=328 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=310 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=351 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=18 Participants Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.
Percent of Participants With Ischemic Stroke Events Ischemic stroke	5.5 Percentage of participants Interval 3.8 to 7.2	4.6 Percentage of participants Interval 2.3 to 6.8	3.8 Percentage of participants Interval 1.7 to 5.9	4.0 Percentage of participants Interval 1.9 to 6.1	3.5 Percentage of participants Interval 1.5 to 5.6	7.7 Percentage of participants Interval 4.9 to 10.5	13.6 Percentage of participants Interval 0.0 to 28.0	5.6 Percentage of participants Interval 0.0 to 16.1
Percent of Participants With Ischemic Stroke Events Undetermined stroke	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0

Adverse Events

Placebo

Serious events: 94 serious events

Other events: 178 other events

Deaths: 5 deaths

Milvexian 25 mg QD

Serious events: 37 serious events

Other events: 81 other events

Deaths: 4 deaths

Milvexian 50 mg QD

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Milvexian 100 mg QD

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Milvexian 25 mg BID

Serious events: 39 serious events

Other events: 83 other events

Deaths: 3 deaths

Milvexian 50 mg BID

Serious events: 41 serious events

Other events: 92 other events

Deaths: 3 deaths

Milvexian 100 mg BID

Serious events: 42 serious events

Other events: 82 other events

Deaths: 5 deaths

Milvexian 200 mg BID

Serious events: 54 serious events

Other events: 90 other events

Deaths: 5 deaths

Serious adverse events

Measure	Placebo n=682 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.
Blood and lymphatic system disorders Anaemia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Acute myocardial infarction	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Angina pectoris	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Angina unstable	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	0.59% 4/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.92% 3/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.98% 3/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Atrial flutter	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Atrial tachycardia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Atrioventricular block complete	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Atrioventricular block second degree	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Bradycardia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Cardiac arrest	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Cardiac failure	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Cardiac failure acute	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Cardiac failure congestive	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Coronary artery disease	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Intracardiac thrombus	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Myocardial infarction	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.65% 2/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Myocardial ischaemia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Nodal rhythm	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Pericarditis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Prinzmetal angina	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Cardiac disorders Sinus tachycardia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo positional	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Eye disorders Retinal detachment	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Faecaloma	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Oesophagitis haemorrhagic	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Pancreatitis acute	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
General disorders Asthenia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
General disorders Pyrexia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
General disorders Sudden cardiac death	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Hepatobiliary disorders Hepatitis fulminant	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Arthritis bacterial	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Bronchitis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations COVID-19	0.73% 5/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Clostridium difficile infection	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Cystitis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Diverticulitis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Febrile infection	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Gastroenteritis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Infected dermal cyst	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Large intestine infection	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Osteomyelitis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Pneumonia	0.44% 3/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.65% 2/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Pneumonia aspiration	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Sepsis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Septic shock	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Tuberculosis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.5% 5/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Urosepsis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Wound infection pseudomonas	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Accidental overdose	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Femur fracture	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Post procedural stroke	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Reactive gastropathy	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Subdural haematoma	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Investigations Ejection fraction decreased	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Investigations Liver function test increased	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Dehydration	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal papilloma	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Aphasia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Basilar artery occlusion	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Basilar artery stenosis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Basilar migraine	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Brain stem stroke	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Carotid artery stenosis	0.59% 4/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Carotid artery thrombosis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Cerebral infarction	0.59% 4/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Cerebral ischaemia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Cerebral venous thrombosis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Dementia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Dysarthria	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Embolic cerebral infarction	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Encephalopathy	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Epilepsy	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Focal dyscognitive seizures	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Generalised tonic-clonic seizure	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Haemorrhagic transformation stroke	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Intracranial aneurysm	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Ischaemic cerebral infarction	0.44% 3/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.96% 3/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.87% 3/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Ischaemic stroke	3.1% 21/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.8% 9/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	13.6% 3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.9% 6/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.1% 10/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.3% 7/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.2% 11/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Lacunar stroke	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Mental impairment	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Myasthenia gravis crisis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Myelopathy	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Neurological symptom	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Partial seizures	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Peroneal nerve palsy	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Pseudostroke	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Sedation complication	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Seizure	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Stroke in evolution	0.73% 5/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.3% 4/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.3% 8/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Syncope	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Toxic encephalopathy	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Transient ischaemic attack	1.2% 8/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.3% 4/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.3% 4/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.2% 4/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Vertebral artery dissection	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Psychiatric disorders Anxiety disorder	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Psychiatric disorders Mania	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	0.44% 3/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.2% 4/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Haematuria	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Nephropathy toxic	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Prerenal failure	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Renal failure	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Hypertension	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Malignant hypertension	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Orthostatic hypotension	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Peripheral artery thrombosis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.

Other adverse events

Measure	Placebo n=682 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Placebo + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Placebo + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg QD n=325 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg QD n=22 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg QD n=17 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg QD + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg QD + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 25 mg BID n=313 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 25 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 25 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 50 mg BID n=325 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 50 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 50 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 100 mg BID n=306 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 100 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 100 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.	Milvexian 200 mg BID n=344 participants at risk Loading dose of Clopidogrel 300 mg + Aspirin 100 mg followed by Milvexian 200 mg BID + Aspirin 100 mg QD + Clopidogrel 75 mg QD on days 1-21 and Milvexian 200 mg BID + Aspirin 100 mg QD on days 22-90. All administered orally.
Blood and lymphatic system disorders Anaemia	0.59% 4/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	11.8% 2/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.6% 5/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.3% 8/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Increased tendency to bruise	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Iron deficiency anaemia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukocytosis	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	0.73% 5/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.92% 3/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.65% 2/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	6.5% 44/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	6.8% 22/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	17.6% 3/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.4% 17/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	6.2% 20/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	6.5% 20/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	7.0% 24/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Flatulence	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gingival bleeding	0.44% 3/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	2.1% 14/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.4% 11/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	11.8% 2/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.9% 6/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.8% 6/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.6% 11/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.5% 5/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Rectal haemorrhage	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	1.0% 7/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.2% 7/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.92% 3/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.98% 3/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.87% 3/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
General disorders Fatigue	0.88% 6/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	11.8% 2/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.96% 3/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.65% 2/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.2% 4/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
General disorders Feeling cold	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
General disorders Non-cardiac chest pain	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
General disorders Thirst	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	2.5% 17/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.5% 8/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.9% 9/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.8% 6/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.6% 11/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.5% 12/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Skin abrasion	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.96% 3/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.98% 3/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.87% 3/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypocalcaemia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Dizziness	1.0% 7/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.2% 4/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.3% 4/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.2% 7/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.6% 5/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.58% 2/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Headache	3.4% 23/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.9% 16/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	13.6% 3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.8% 12/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.3% 14/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	3.9% 12/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.6% 9/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Paraesthesia	0.44% 3/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	11.8% 2/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Syncope	0.15% 1/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.92% 3/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Nervous system disorders Tremor	0.44% 3/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Psychiatric disorders Anxiety	0.73% 5/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.92% 3/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.9% 6/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.92% 3/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.6% 5/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.87% 3/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Psychiatric disorders Depressed mood	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Psychiatric disorders Disorientation	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Psychiatric disorders Mental status changes	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	11.8% 2/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.32% 1/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	2.6% 9/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Renal and urinary disorders Pollakiuria	0.29% 2/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.65% 2/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.29% 1/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.5% 10/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.3% 4/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.5% 5/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.3% 4/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.7% 6/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.31% 1/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Hypertension	8.2% 56/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	6.5% 21/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	11.8% 2/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	7.3% 23/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	7.4% 24/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	6.5% 20/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.5% 19/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
Vascular disorders Hypotension	0.73% 5/682 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.62% 2/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	5.9% 1/17 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.64% 2/313 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	1.2% 4/325 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.33% 1/306 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.	0.87% 3/344 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 7 days after last dose of study therapy (up to approximately 112 days). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

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

Restriction type: OTHER